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amendment list, 28 July 2026

Amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and amending Regulation (EU) 2022/123 as regards the support of the European Medicines Agency for the expert panels on medical devices and Regulation (EU) 2024/1689 as regards the list of Union harmonisation legislation referred to in its Annex I

Document SANT-AM-791891 · (COM(2025)1023 – 2025/0404(COD))

Committee on Public Health

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Text 2,080 paragraphs

Amendment 616

Andreas Glück, Stine Bosse, Billy Kelleher

Proposal for a regulation

Article 1 – paragraph 1 – point 86

Regulation (EU) 2017/745

Article 106 – paragraph 7

Text proposed by the CommissionAmendment
7. In addition to the tasks assigned to them in other provisions of this Regulation and of Regulation (EU) 2017/746, the expert panels may have the following tasks:7. In addition to the tasks assigned to them in other provisions of this Regulation and of Regulation (EU) 2017/746, the expert panels shall support the MDCG and the Commission in the following tasks:

Or. en

Justification

Expert panels should provide scientific, clinical and technical advice — regulatory authority stays with Member States via the MDCG ('support', not independent tasks). Adding patient representatives with disease-area experience as full members increases legitimacy and real-world relevance, following the EMA model.

Amendment 617

Andreas Glück, Stine Bosse, Billy Kelleher

Read the rest (2,068 paragraphs)

Proposal for a regulation

Article 1 – paragraph 1 – point 86

Regulation (EU) 2017/745

Article 106 – paragraph 7 – point a

Text proposed by the CommissionAmendment
(a) to provide scientific, clinical, technical and regulatory advice to the Commission, the MDCG, Member States or notified bodies in relation to the implementation of this Regulation or Regulation (EU) 2017/746;(a) to provide scientific, clinical, technical advice in relation to the implementation of this Regulation or Regulation (EU) 2017/746;

Or. en

Amendment 618

Kateřina Konečná

Proposal for a regulation

Article 1 – paragraph 1 – point 86

Regulation (EU) 2017/745

Article 106 – paragraph 8 a (new)

Text proposed by the CommissionAmendment
8a. Persons with lived experience contributing to the work of expert panels pursuant to paragraphs 4 or 5 shall be remunerated on terms equivalent to those applicable to other experts, and shall have access to the training, documentation and support necessary to participate effectively.

Or. en

Amendment 619

Letizia Moratti, Dolors Montserrat, Elena Nevado del Campo

Proposal for a regulation

Article 1 – paragraph 1 – point 87

Regulation (EU) 2017/745

Article 106b – paragraph 1

Text proposed by the CommissionAmendment
1. The EMA shall, on behalf of the Commission, provide scientific, technical and administrative support to the national competent authorities designated under this Regulation and under Regulation (EU) 2017/746 to facilitate the exchange of experience, cooperation and coordination with a view to ensuring a uniform application of such Regulations, in particular in the following areas:1. The EMA shall, on behalf of the Commission, provide administrative support to the national competent authorities designated under this Regulation and under Regulation (EU) 2017/746 to facilitate the exchange of experience, cooperation and coordination with a view to ensuring a uniform application of such Regulations, in particular in the following areas:

Or. en

Amendment 620

Ruggero Razza, Michele Picaro

Proposal for a regulation

Article 1 – paragraph 1 – point 87

Regulation (EU) 2017/745

Article 106b – paragraph 1

Text proposed by the CommissionAmendment
1. The EMA shall, on behalf of the Commission, provide scientific, technical and administrative support to the national competent authorities designated under this Regulation and under Regulation (EU) 2017/746 to facilitate the exchange of experience, cooperation and coordination with a view to ensuring a uniform application of such Regulations, in particular in the following areas:1. The EMA shall, on behalf of the Commission, provide administrative support to the national competent authorities designated under this Regulation and under Regulation (EU) 2017/746 to facilitate the exchange of experience, cooperation and coordination with a view to ensuring a uniform application of such Regulations, in particular in the following areas:

Or. it

Justification

Article 106b expands the EMA’s role in product qualification, despite the MDCG being strengthened and a new expert panel established, increasing procedural complexity. As its mandate mainly covers medicinal products, in borderline cases related to non-pharmacological devices, the EMA should only provide technical administrative support, without decision-making powers, to protect regulatory certainty, innovation and competitiveness.

Amendment 621

Ruggero Razza, Michele Picaro

Proposal for a regulation

Article 1 – paragraph 1 – point 87

Regulation (EU) 2017/745

Article 106a – paragraph 1 – point a

Text proposed by the CommissionAmendment
(a) regulatory status of products and classification of devices in accordance with Articles 4, 4a, 51, 51a and 51b of this Regulation and Articles 3, 3a, 47, 47a and 47b of Regulation (EU) 2017/746;deleted

Or. it

Amendment 622

Letizia Moratti, Dolors Montserrat, Elena Nevado del Campo

Proposal for a regulation

Article 1 – paragraph 1 – point 87

Regulation (EU) 2017/745

Article 106a – paragraph 1 – point a

Text proposed by the CommissionAmendment
(a) regulatory status of products and classification of devices in accordance with Articles 4, 4a, 51, 51a and 51b of this Regulation and Articles 3, 3a, 47, 47a and 47b of Regulation (EU) 2017/746;deleted

Or. en

Amendment 623

Kristoffer Storm

Proposal for a regulation

Article 1 – paragraph 1 – point 87

Regulation (EU) 2017/746

Article 106b – paragraph 1 – subparagraph 2

Text proposed by the CommissionAmendment
(da) devices which incorporate, as an integral part, a substance which, if used separately, would be considered to be a medicinal product as defined in point 2 of Article 1 of Directive 2001/83/EC, as referred to in Article 1(8) and Article 1(9) of this Regulation, including coordination with notified bodies, national competent authorities and, where appropriate, EMA’s Combination Products Operational Group, to ensure consistent application across the Union of the relevant general safety and performance requirements set out in Annex I to this Regulation in respect of the device part of such product, and to facilitate the exchange of scientific and regulatory expertise throughout the lifecycle of such products.

Or. en

Amendment 624

Andreas Glück, Stine Bosse, Billy Kelleher

Proposal for a regulation

Article 1 – paragraph 1 – point 87

Regulation (EU) 2017/745

Article 106b – paragraph 1 – point da (new )

Text proposed by the CommissionAmendment
1a. devices which incorporate, as an integral part, a substance which, if used separately, would be considered to be a medicinal product as defined in point 2 of Article 1 of Directive 2001/83/EC, as referred to in Article 1(8) and Article 1(9) of this Regulation, including coordination with notified bodies, national competent authorities and, where appropriate, EMA’s Combination Products Operational Group, to ensure consistent application across the Union of the relevant general safety and performance requirements set out in Annex I to this Regulation in respect of the device part of such product, and to facilitate the exchange of scientific and regulatory expertise throughout the lifecycle of such products.

Or. en

Justification

Art. 117 duplicates requirements now contained in the General Pharmaceutical Legislation — the same obligation in two laws creates ambiguity and dual compliance burden. Deleting it removes the duplication (the requirement remains in the GPL). The new Art. 106b(1)(e) gives EMA explicit coordination via its COMBO group: one-door entry, consistent application of the GSPRs, and shorter, more predictable reviews. Around 20% of EMA marketing authorisation applications involve combination products.

Amendment 625

Laurence Trochu

Proposal for a regulation

Article 1 – paragraph 1 – point 90

Regulation (EU) 2017/745

Article 108a – paragraph 4

Text proposed by the CommissionAmendment
The Commission may sign administrative arrangements with authorities of third countries and with international organisations for the purpose of regulatory cooperation in the field of medical devices and in vitro diagnostic medical devices, including:With the agreement of the Council of the EU, the Commission may sign administrative arrangements with authorities of third countries and with international organisations for the purpose of regulatory cooperation in the field of medical devices and in vitro diagnostic medical devices, including:

Or. fr

Justification

The administrative arrangements signed by the Commission on international cooperation could be legally binding for the Member States. They should, therefore, be involved in the decision, in accordance with the principle of mutual sincere cooperation and Article 13 TEU.

Amendment 626

Michele Picaro, Ruggero Razza

Proposal for a regulation

Article 1 – paragraph 1 – point 90 a (new)

Regulation (EU) 2017/745

Article 110

Text proposed by the CommissionAmendment
(90a) Article 110 is deleted;

Or. en

Amendment 627

Michele Picaro, Ruggero Razza

Proposal for a regulation

Article 1 – paragraph 1 – point 90 b (new)

Regulation (EU) 2017/745

Article 110a (new)

Text proposed by the CommissionAmendment
(90b) the following Article 110a is inserted:
Article 110a
Processing of personal data in the activities governed by this Regulation
1. The processing of personal data, including health data and genetic data, in compliance with the obligations of this Regulation shall be carried out pursuant to Article 6(1)(c) of Regulation (EU) 2016/679. For special categories of personal data it shall be carried out pursuant to Article 9(2)(j) of that Regulation, with the safeguards under Article 89(1), for the purposes referred to in paragraph 2, point (a), and pursuant to Article 9(2)(i) for the remaining purposes referred to in paragraph 2, in so far as necessary to ensure high standards of quality and safety of medical devices and in vitro diagnostic medical devices.
2. Processing shall be carried out, to the extent necessary, for the following purposes:
a) the conduct and management of [the clinical investigations / the performance studies], including authorization, monitoring, the recording and reporting of serious adverse events and device deficiencies, the submission of the report and the archiving of the master file;
b) post-market surveillance, including post-market clinical follow-up, post-market performance follow-up and the reports provided for by this Regulation;
c) vigilance, including the recording, reporting and management of serious incidents and field safety corrective actions, and trend reporting;
d) the cybersecurity of connected devices, including the reporting of actively exploited vulnerabilities and serious cybersecurity incidents;
e) the identification and traceability of devices and economic operators, and the populating of Eudamed and of the other electronic systems provided by this Regulation.
The categories of personal data and of data subjects shall be specified, for [the clinical investigations / the performance studies], in the authorized protocol and, for the remaining purposes, in the planning and management documents provided for by this Regulation.
3. Personal data shall be stored for the period required by the relevant provisions of this Regulation. The data collected pursuant to paragraph 2 may be further processed by the same controller, pursuant to Article 6(1)(e) of Regulation (EU) 2016/679 and in compliance with the basis under Article 9(2) referred to in paragraph 1, for other [clinical investigations / performance studies], for post-market clinical follow-up and post-market performance follow-up, and for research aimed at ensuring high standards of quality, safety and performance of devices, subject to pseudonymization, the establishment of appropriate governance structures, confidentiality obligations of staff and information of the data subjects.
4. Controllers shall implement appropriate and specific measures to safeguard the rights and freedoms of data subjects pursuant to Articles 5, 24, 25, 32 and — where relevant — 89 of Regulation (EU) 2016/679, including, in particular:
a) the pseudonymization of personal data and the adoption of technical and organizational measures suitable to ensure their integrity, confidentiality and controlled access, including confidentiality obligations of staff; the processing of directly identifiable data shall be permitted only where necessary to achieve the purpose pursued;
b) the transmission of personal data to the competent authorities of the Member States, to the Commission and to the notified bodies solely to the extent necessary for the performance of their respective tasks, as a rule in pseudonymized form;
c) the identification, in the planning and management documents referred to in paragraph 2, of the further specific technical and organizational measures.
5. By way of derogation from Article 9(4) of Regulation (EU) 2016/679, Member States may not maintain or introduce, with regard to the processing of personal data, including health data and genetic data, carried out pursuant to this Article, further conditions, including limitations and specific provisions.;

Or. en

Amendment 628

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 94

Regulation (EU) 2017/745

Article 116

Text proposed by the CommissionAmendment
(94) Article 116 is deleted;deleted

Or. en

Amendment 629

Kristoffer Storm

Proposal for a regulation

Article 1 – paragraph 1 – point 94 a (new)

Regulation (EU) 2017/745

Article 117

Present textAmendment
(94a) Article 117 is deleted
Article 117""
Amendment to Directive 2001/83/EC
InAnnex I to Directive 2001/83/EC, point 12 of Section 3.2. is replaced by the following:‘
(12)Where, in accordance with the second subparagraph of Article 1(8) or the second subparagraph of Article 1(9) of Regulation (EU) 2017/745 of the European Parliament and of the Council (*1), a product is governed by this Directive, the marketing authorisation dossier shall include, where available, the results of the assessment of the conformity of the device part with the relevant general safety and performance requirements set out in Annex I to that Regulation contained in the manufacturer's EU declaration of conformity or the relevant certificate issued by a notified body allowing the manufacturer to affix a CE marking to the medical device.

Or. en

(Regulation (EU) 2017/745)

Amendment 630

Andreas Glück, Stine Bosse, Billy Kelleher

Proposal for a regulation

Article 1 – paragraph 1 – point 94 a (new)

Regulation (EU) 2017/745

Article 117

Present textAmendment
(94 a) Article 117 is deleted
Amendment to Directive 2001/83/EC""
In Annex I to Directive 2001/83/EC, point 12 of Section 3.2. is replaced by the following: ‘(12) Where, in accordance with the second subparagraph of Article 1(8) or the second subparagraph of Article 1(9) of Regulation (EU) 2017/745 of the European Parliament and of the Council (*), a product is governed by this Directive, the marketing authorisation dossier shall include, where available, the results of the assessment of the conformity of the device part with the relevant general safety and performance requirements set out in Annex I to that Regulation contained in the manufacturer's EU declaration of conformity or the relevant certificate issued by a notified body allowing the manufacturer to affix a CE marking to the medical device.

Or. en

(Regulation (EU) 2017/745)

Amendment 631

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 96

Regulation (EU) 2017/745

Article 121 – paragraphs 1a (new), 1b (new) and 1c (new)

Text proposed by the CommissionAmendment
2. The evaluation shall, in particular, assess:
(a) whether the simplification measures introduced by this Regulation have had any unintended consequences affecting the safety or performance of medical devices, the effectiveness of market surveillance, vigilance or post-market surveillance activities, or the overall level of protection of public health.
(b) the effectiveness of the measures introduced to simplify the regulatory framework and reduce the administrative burden on manufacturers, notified bodies and competent authorities, including their impact on regulatory efficiency, legal certainty and the timely availability of medical devices on the Union market;
(c) the impact of the reduction or adaptation of notified body fees and other measures intended to improve access to conformity assessment, including their effect on the capacity, availability and geographical distribution of notified bodies, particularly for micro, small and medium-sized enterprises;
(d) the functioning and effectiveness of the regulatory sandboxes established under this Regulation, including their contribution to innovation, regulatory learning, regulatory convergence and the development of guidance, common specifications, implementing acts or legislative proposals;
(e) the effectiveness of the framework for well-established technologies, including its impact on regulatory efficiency, innovation, patient access, post-market safety and whether the eligibility criteria remain appropriate in light of scientific and technological developments;
(f) the application of the accelerated conformity assessment pathway for orphan devices and breakthrough devices, including its impact on timely patient access, innovation, the generation of clinical evidence, post-market clinical follow-up, patient safety and the availability of such devices across the Union;
(g) the impact of the revised classification rules for software and the simplified approach to low-risk software modifications on innovation, regulatory burden, cybersecurity, patient safety and the performance of software-based medical devices, including software incorporating artificial intelligence where applicable;
(h) the impact of the measures strengthening stakeholder involvement, including the participation of patients, healthcare professionals and their representative organisations in the work of the MDCG, expert panels, vigilance activities and Eudamed, and their contribution to the transparency, quality and legitimacy of regulatory decision-making;
(i) the functioning of Eudamed, including its contribution to transparency, traceability, coordination between Member States, access to information for patients, healthcare professionals and the public, and the effectiveness of its publicly accessible modules; (k) the effectiveness of the measures introduced to improve the availability of medical devices and to prevent or mitigate shortages, including their impact on the continuity of supply of critical medical devices within the Union;
(j) the impact of the measures introduced to facilitate structured scientific, technical and regulatory dialogue between manufacturers and notified bodies on the efficiency, predictability and quality of conformity assessment procedures, while preserving the independence, objectivity and impartiality of notified bodies;
(k) whether the measures introduced by this Regulation have maintained an appropriate balance between facilitating innovation and market access and ensuring the generation of sufficient clinical evidence throughout the lifecycle of medical devices, including through post-market clinical follow-up and post-market surveillance.
3. The evaluation shall be based, inter alia, on information provided by Member States, competent authorities, the Medical Device Coordination Group, expert panels, notified bodies, manufacturers, healthcare professionals, patient organisations and other relevant stakeholders, as well as data available through the EUDAMED.
4. The Commission shall make the findings of the evaluation publicly available. Where appropriate, the Commission shall accompany the report with legislative proposals to amend this Regulation.

Or. en

Amendment 632

Laurence Trochu

Proposal for a regulation

Article 1 – paragraph 1 – point 96

Regulation (EU) 2017/745

Article 121 – paragraph 1

Text proposed by the CommissionAmendment
No sooner than … [Publications Office, please insert the date five years after the date of application of this Regulation], the Commission shall carry out an evaluation of this Regulation and present a report on the main findings to the European Parliament and the Council.No sooner than … [Publications Office, please insert the date three years after the date of application of this Regulation], the Commission shall carry out an evaluation of this Regulation and present a report on the main findings to the European Parliament and the Council. As part of this evaluation, the Commission shall carry out an in-depth impact assessment of brain-machine interfaces, especially those incorporating artificial intelligence, in order to evaluate, in particular, the ethical dimension, the risk of harm to mental integrity and cognitive liberty, and the therapeutic prospects. It shall forward its report to the European Parliament and the Council, indicating the conditions under which such devices could be marketed.

Or. fr

Amendment 633

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 96

Regulation (EU) 2017/745

Article 121 – paragraph 1

Text proposed by the CommissionAmendment
No sooner than …[Publications Office, please insert the date five years after the date of application of this Regulation], the Commission shall carry out an evaluation of this Regulation and present a report on the main findings to the European Parliament and the Council.No later than... [Publications Office, please insert the date five years after the date of application of the Amendment], and every 10 years thereafter, the Commission shall carry out an evaluation of this Regulation and present a report on the main findings to the European Parliament and the Council. The evaluation shall assess whether the measures introduced by this Regulation have achieved their objectives while maintaining the high level of protection of health and safety of patients, users and other persons provided for by this Regulation.

Or. en

Amendment 634

Tiemo Wölken

Proposal for a regulation

Article 1 – paragraph 1 – point 96

Regulation (EU) 2017/745

Article 121 – paragraph 2

Text proposed by the CommissionAmendment
Member States and notified bodies shall provide the Commission with the information necessary for the preparation of that report.Member States,notified bodies and, where needed, relevant stakeholders including patient and consumer organisations, healthcare professionals and manufacturers, shall provide the Commission with the information necessary for the preparation of that report.

Or. en

Amendment 635

Adam Jarubas

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point d

Regulation (EU) 2017/746

Article 2 – point 78a (new)

Text proposed by the CommissionAmendment
(78a) ‘connected device’ means an active device which intended purpose or reasonably foreseeable use of which includes a direct or indirect logical or physical data connection to a device or network, based on the definitions: ‘logical connection’, ‘physical connection’ and ‘indirect connection’ included in article 3 of Regulation (EU) 2024/2847 of the European Parliament and of the Council.

Or. en

Amendment 636

Andreas Glück, Stine Bosse, Billy Kelleher

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point d a (new)

Regulation (EU) 2017/746

Article 2 – point 78a (new)

Text proposed by the CommissionAmendment
(da) the following point is added:
‘Breakthrough device’ means a breakthrough device as defined in Regulation 2017/745 (consolidated).

Or. en

Amendment 637

Andreas Glück, Stine Bosse, Billy Kelleher

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point d b (new)

Regulation (EU) 2017/746

Article 2 – point 78b (new)

Text proposed by the CommissionAmendment
(db) the following point is added:
‘Orphan device’ means an orphan device as defined in Regulation 2017/745 (consolidated)

Or. en

Amendment 638

Andreas Glück, Stine Bosse, Billy Kelleher

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point d c (new)

Regulation (EU) 2017/746

Article 2 – point 78c (new)

Text proposed by the CommissionAmendment
(dc) the following point is added:
‘Paediatric device’ means a paediatric device as defined in Regulation 2017/745 (consolidated)

Or. en

Amendment 639

Ruggero Razza, Michele Picaro

Proposal for a regulation

Article 2 – paragraph 1 – point 3

Regulation (EU) 2017/746

Article 3 – paragraph 1

Text proposed by the CommissionAmendment
1. The competent authorities of the Member States shall coordinate their activities when determining whether a specific product, or category or group of products, falls within the definition of an ‘in vitro diagnostic medical device’ or of an ‘accessory for an in vitro diagnostic medical device’.1. The competent authorities of the Member States shall coordinate their activities when determining whether a specific product that has already been placed on the market falls within the definition of an ‘in vitro diagnostic medical device’ or of an ‘accessory for an in vitro diagnostic medical device’.

Or. it

Justification

In line with the case law of the Court of Justice of the European Union, the regulatory status of a product must be assessed on a case-by-case basis. The reference to categories or groups of products should therefore be deleted.

Amendment 640

Ruggero Razza, Michele Picaro

Proposal for a regulation

Article 2 – paragraph 1 – point 3

Regulation (EU) 2017/746

Article 3 – paragraph 3

Text proposed by the CommissionAmendment
3. Where a competent authority of a Member State, after having performed an evaluation in accordance with Article 89, considers that a product that is CE marked in accordance with Article 18, does not fall within the scope of this Regulation, it shall consult the competent authorities of the other Member States regarding its envisaged measure determining the regulatory status of the product in question.3. Where a competent authority of a Member State, after having performed an evaluation in accordance with Article 89 and taking account of the provisions of paragraph 5a, has substantial evidence that a product that is CE marked in accordance with Article 18, does not fall within the scope of this Regulation, it shall consult the competent authorities of the other Member States regarding its envisaged measure determining the regulatory status of the product in question.

Or. it

Justification

It is essential that, before questioning the regulatory status of a device already placed on the market, the competent authority has documented evidence to support its doubts as to the qualification of the device.

Amendment 641

Ruggero Razza, Michele Picaro

Proposal for a regulation

Article 2 – paragraph 1 – point 3

Regulation (EU) 2017/746

Article 3 – paragraph 5a (new)

Text proposed by the CommissionAmendment
5a. For products bearing the CE marking and for which the conformity assessment referred to in Article 48 involved a notified body, the procedure set out in this Article shall only apply where the competent authority concerned has substantiated evidence that the regulatory status of the product as an in vitro diagnostic medical device poses an unacceptable risk within the meaning of Article 89(a). The regulatory status of the product does not in itself constitute such proof.

Or. it

Justification

To provide legal certainty to the medical devices and IVD industry and to reaffirm the value of the EC certificate as proof of conformity, the regulatory status of a product already on the market should only be reassessed under clearly defined conditions and where there is an unacceptable risk for patients. In the absence of such conditions, the EC certificate shall be considered as a guarantee of conformity of the device.

Amendment 642

Ruggero Razza, Michele Picaro

Proposal for a regulation

Article 2 – paragraph 1 – point 3

Regulation (EU) 2017/746

Article 3 – paragraph 5b (new)

Text proposed by the CommissionAmendment
5b. Having regard to the expert panel opinion referred to in Article 3(4), a Member State may submit a substantiated request to the Commission to determine whether a specific product falls within the definition of ‘in vitro diagnostic medical device’ or of ‘accessory for an in vitro diagnostic medical device’. The Commission shall decide on the substantiated request of the Member State, or on its own initiative, by means of implementing acts, which shall be adopted in accordance with the examination procedure referred to in Article 107(3). The Commission may ask the expert panel for clarifications or refer the opinion back to the expert panel for further consideration, including in cases where a Member State’s substantiated request raises new questions of a scientific or technical nature.

Or. it

Justification

Paragraph 5aa has been moved from Article 3a(3), as it should only apply to products already certified and placed on the market, not to those under development. For the latter, in case of disagreement between the manufacturer and the notified body, the qualification shall be the responsibility of the competent authority of the Member State where the manufacturer has its registered place of business. This avoids EU intervention before technical characteristics and the intended use are defined.

Amendment 643

Ruggero Razza, Michele Picaro

Proposal for a regulation

Article 2 – paragraph 1 – point 3

Regulation (EU) 2017/746

Article 3 – paragraph 5c (new)

Text proposed by the CommissionAmendment
5c. Where, as a result of the coordination mechanism or any subsequent regulatory assessment, a different regulatory status is deemed to apply to that product, the clinical data, non-clinical data, post-market surveillance and vigilance data and any other evidence from real-world use generated or collected during the period in which the product was lawfully placed on the market as an in vitro diagnostic medical device shall remain admissible and may be taken into account for the purposes of any subsequent regulatory application or assessment, where relevant and scientifically valid.

Or. it

Justification

When assessing the attribution to a product of a status other than that of an in vitro diagnostic medical device, the competent authority should consider its ability to comply with all applicable requirements, taking into account clinical, non-clinical, post-market, vigilance data and real-world use. This avoids requalification making it de facto impossible for them to be marketed under an alternative regulatory framework.

Amendment 644

Ruggero Razza, Michele Picaro

Proposal for a regulation

Article 2 – paragraph 1 – point 4

Regulation (EU) 2017/746

Article 3a – paragraph 1

Text proposed by the CommissionAmendment
1. A competent authority, a notified body, a manufacturer, a developer of a product or the Commission may submit a substantiated request for an opinion from an expert panel referred to in Article 106 of Regulation (EU) 2017/745 on the question whether a specific product, or category or group of products, falls within the definitions of ‘in vitro diagnostic medical device’ or ‘accessory for an in vitro diagnostic medical device’. Where, in such a request, the requester considers that the product in question is an in vitro diagnostic medical device, the request shall also specify the proposed classification of the device in accordance with Article 47 and Annex VIII.1. A competent authority may submit a substantiated request for an opinion from an expert panel referred to in Article 106 of Regulation (EU) 2017/745 on the question whether a specific product falls within the definitions of ‘in vitro diagnostic medical device’ or ‘accessory for an in vitro diagnostic medical device’. Where, in such a request, the requester considers that the product in question is an in vitro diagnostic medical device, the request shall also specify the proposed classification of the device in accordance with Article 47 and Annex VIII.

Or. it

Justification

The mechanism should only apply to IVDs not yet EC certified or placed on the market, as those already placed on the market are covered by Article 3. This limit makes it possible to resolve qualification issues before certification, ensuring legal certainty and predictability. The procedure should only be triggered by the competent authorities, without other actors having a direct role, including the developer – a term not defined by the Regulation.

Amendment 645

Laurent Castillo, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain, Valérie Deloge, Viktória Ferenc

Proposal for a regulation

Article 2 – paragraph 1 – point 4

Regulation (EU) 2017/746

Article 3a – paragraph 2

Text proposed by the CommissionAmendment
2. The expert panel shall provide its opinion without undue delay. The requester shall give utmost consideration to the opinion of the expert panel.2. The expert panel shall provide its opinion within 60 days of receipt of the request. The requester shall give utmost consideration to the opinion of the expert panel.

Or. fr

Amendment 646

Ruggero Razza, Michele Picaro

Proposal for a regulation

Article 2 – paragraph 1 – point 5 – point a – point i – point 3

Regulation (EU) 2017/746

Article 5 – paragraph 5 – subparagraph 1 – point d

Text proposed by the CommissionAmendment
(3) point (d) is deleted;(3) point (d) is amended as follows:
(d) the health institution justifies in its documentation that the target patient group’s specific needs cannot be met, or cannot be met at the appropriate level of performance by an equivalent device available on the market;

Or. it

Justification

The increased flexibility for in-house devices is welcomed, but the transition to a CE marked equivalent should take place within 3 years, based on a plan that ensures continuity of care and patient safety. The maximum period of 10 years is excessive. We also propose deleting paragraph 7, as amendments to the GSPRs in Annex I should remain subject to the ordinary legislative procedure.

Amendment 647

Kateřina Konečná

Proposal for a regulation

Article 2 – paragraph 1 – point 5 – point a – point i – point 4

Regulation (EU) 2017/746

Article 5 – paragraph 5 – subparagraph 1 – point e

Text proposed by the CommissionAmendment
(e) upon request by a competent authority, the health institution provides information on the use of such devices to its competent authority, which shall include the justification referred to in point (a);;(e) upon request by a competent authority, the health institution provides information on the use of such devices and if and how they are shared with other health institutions, to its competent authority, which shall include the justification referred to in point (a);

Or. en

Amendment 648

Viktória Ferenc, Ondřej Knotek, Laurent Castillo, Valérie Deloge

Proposal for a regulation

Article 2 – paragraph 1 – point 5 – point a – point i – point 4

Regulation (EU) 2017/746

Article 2 – points 78a (new), 78b (new) and 78c (new)

Text proposed by the CommissionAmendment
(ea) The following points are added:
(78) ‘breakthrough device’ means a novel medical device or in vitro diagnostic medical device expected to provide a significant positive clinical benefit through either of the following:
- Offering a significant positive clinical impact on patients or public health compared to available alternatives and the state of the art, or
- Fulfilling an unmet medical need where there is an absence or insufficiency of available alternative options for that purpose.
(79): 'orphan devices' means a medical device intended for a disease or condition affecting not more than 12,000 individuals in the Union per year and’;
- there is insufficiency of available alternative options for the treatment, diagnosis, or prevention of this disease/condition, or
- the device will offer an option that will provide an expected clinical benefit compared to available alternatives or state of the art for the treatment, diagnosis, or prevention of this disease/condition, taking into account both device and patient population specific factors.
(79a) ‘orphan IVD device’ means an in vitro diagnostic medical device intended to provide information on a disease or condition that presents in not more than 5 in 10 000 individuals in the Union per year;
- there is insufficiency of available alternative options for the treatment, diagnosis, or prevention of this disease/condition, or
- the device will provide a clinical benefit compared to available alternatives or the state of the art (80) ‘paediatric device’ means a medical devices intended for a use in the age group until 18 years of age. Further factors may need to be considered.

Or. en

Justification

Clear and objective definitions establish transparent eligibility criteria for the regulatory measures applicable to these categories of devices, while ensuring that such measures are reserved for devices addressing unmet medical needs, rare diseases or conditions, or specific paediatric populations. This contributes to a predictable regulatory framework that supports innovation without compromising the high level of protection of health and safety required by this Regulation.

Amendment 649

Kateřina Konečná

Proposal for a regulation

Article 2 – paragraph 1 – point 5 – point a – point i – point 5

Regulation (EU) 2017/746

Article 5 – paragraph 5 – point f – point iii

Text proposed by the CommissionAmendment
(iii) a declaration either that the health institution is accredited to the standard referred to in point (c) or that the devices meet the relevant general safety and performance requirements set out in Annex I and, where applicable, information on which requirements are not fully met with a reasoned justification therefor;;(iii) a declaration either that the health institution is accredited to the standard referred to in point (c) or that the devices meet the relevant general safety and performance requirements set out in Annex I and, where applicable, information on which requirements are not fully met with a reasoned justification therefor. The declaration requirements shall be implemented in a harmonised manner throughout the Union in order to ensure their consistent application by the Member States, while avoiding unnecessary duplication of conformity assessment or quality review procedures.

Or. en

Amendment 650

Tiemo Wölken

Proposal for a regulation

Article 2 – paragraph 1 – point 5 – point a – point i – point 5

Regulation (EU) 2017/746

Article 5 – paragraph 5 – point f – point iii

Text proposed by the CommissionAmendment
(iii) a declaration either that the health institution is accredited to the standard referred to in point (c) or that the devices meet the relevant general safety and performance requirements set out in Annex I and, where applicable, information on which requirements are not fully met with a reasoned justification therefor;;(iii) a declaration that the health institution is accredited to the standard referred to in point (c) and that the devices meet the relevant general safety and performance requirements set out in Annex I and, where applicable, information on which requirements are not fully met with a reasoned justification therefor;;

Or. en

Amendment 651

Tiemo Wölken

Proposal for a regulation

Article 2 – paragraph 1 – point 5 – point a – point iii

Regulation (EU) 2017/746

Article 5 – paragraph 5 – subparagraph 4

Text proposed by the CommissionAmendment
For the purposes of the first subparagraph, point (a), in the case of a transfer of the device to another health institution, the transferring and receiving health institutions shall ensure traceability of the device.For the purposes of the first subparagraph, point (a), in the case of a transfer of the device to another health institution, the transferring and receiving health institutions shall ensure the traceability of the device, including, where applicable, by recording the Unique Device Identifier (UDI), the identity of the transferring and receiving health institutions and information relating to any reprocessing carried out.

Or. en

Amendment 652

Ruggero Razza, Michele Picaro

Proposal for a regulation

Article 2 – paragraph 1 – point 5 – point a – point iii

Regulation (EU) 2017/746

Article 5 – paragraph 5 – subparagraph 1a (new)

Text proposed by the CommissionAmendment
For the purposes of the first subparagraph, point (d), from the date that the health institution becomes aware that the target patient group’s specific needs can be met by a device available on the market, it may continue to manufacture and use its device for a maximum period of 3 years.

Or. it

Justification

See the rationale for Article 5(5).

Amendment 653

Stine Bosse, Billy Kelleher

Proposal for a regulation

Article 2 – paragraph 1 – point 5 – point a a (new)

Regulation (EU) 2017/746

Article 5 – paragraph 5 – introductory part

Text proposed by the CommissionAmendment
(aa) in paragraph 5, the introductory part is replaced by the following: "5. With the exception of the relevant general safety and performance requirements set out in Annex I, the requirements of this Regulation shall not apply to devices manufactured and used only within health institutions established in the Union provided that all of the following conditions are met:

Or. en

Justification

The rapporteur's text opens the door to laboratories established outside the Union. This creates risk for patients because EU competent authorities have no equivalent power to inspect or enforce the applicable requirements against a laboratory established in a third country.

Accreditation status alone does not establish that a third- country institution operates under a regulatory framework with comparable oversight, enforcement powers, and patient safety safeguards; it only confirms that the laboratory meets a technical standard, not that a competent authority stands behind it.

The practical risk to patients is that a laboratory-developed test manufactured outside the Union could reach EU patients via cross-border sample referral, with no EU or Member State authority able to inspect the originating laboratory or enforce corrective action if something goes wrong.

Amendment 654

Laurence Trochu

Proposal for a regulation

Article 2 – paragraph 1 – point 5 – point b

Regulation 2017/746

Article 5 – paragraph 7

Text proposed by the CommissionAmendment
7. The Commission is empowered to adopt delegated acts in accordance with Article 108, to amend the general safety and performance requirements set out in Annex I in order to adapt them to scientific or technical progress or to international developments, or to add requirements in relation to emerging risks or technologies.deleted

Or. fr

Amendment 655

Ruggero Razza, Michele Picaro

Proposal for a regulation

Article 2 – paragraph 1 – point 5 – point b

Regulation (EU) 2017/746

Article 5 – paragraph 7

Text proposed by the CommissionAmendment
7. The Commission is empowered to adopt delegated acts in accordance with Article 108, to amend the general safety and performance requirements set out in Annex I in order to adapt them to scientific or technical progress or to international developments, or to add requirements in relation to emerging risks or technologies.deleted

Or. it

Justification

See the rationale for Article 5(5).

Amendment 656

Tiemo Wölken

Proposal for a regulation

Article 2 – paragraph 1 – point 5 – point b

Regulation (EU) 2017/746

Article 5 – paragraph 8

Text proposed by the CommissionAmendment
When adopting implementing acts pursuant to paragraph 6 of this Article, delegated acts pursuant to paragraph 7 of this Article or Common Specifications pursuant to Article 9 of this Regulation concerning devices that are high-risk AI systems as referred to in Article 6(1) of Regulation (EU) 2024/1689 of the European Parliament and of the Council**, or that use high-risk AI systems as safety components, the Commission shall take into account the requirements set out in Chapter III, Section 2, of that Regulation.deleted

Or. en

Amendment 657

Ignazio Roberto Marino

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 2 – paragraph 1 – point 5 – point b

Regulation (EU) 2017/746

Article 5 – paragraph 8

Text proposed by the CommissionAmendment
When adopting implementing acts pursuant to paragraph 6 of this Article, delegated acts pursuant to paragraph 7 of this Article or Common Specifications pursuant to Article 9 of this Regulation concerning devices that are high-risk AI systems as referred to in Article 6(1) of Regulation (EU) 2024/1689 of the European Parliament and of the Council**, or that use high-risk AI systems as safety components, the Commission shall take into account the requirements set out in Chapter III, Section 2, of that Regulation.deleted

Or. en

Amendment 658

Laurence Trochu

Proposal for a regulation

Article 2 – paragraph 1 – point 5 – point b

Regulation (EU) 2017/746

Article 5 – paragraph 8

Text proposed by the CommissionAmendment
When adopting implementing acts pursuant to paragraph 6 of this Article, delegated acts pursuant to paragraph 7 of this Article or Common Specifications pursuant to Article 9 of this Regulation concerning devices that are high-risk AI systems as referred to in Article 6(1) of Regulation (EU) 2024/1689 of the European Parliament and of the Council**, or that use high-risk AI systems as safety components, the Commission shall take into account the requirements set out in Chapter III, Section 2, of that Regulation.When adopting implementing acts pursuant to paragraph 6 of this Article or Common Specifications pursuant to Article 9 of this Regulation concerning devices that are high-risk AI systems as referred to in Article 6(1) of Regulation (EU) 2024/1689 of the European Parliament and of the Council**, or that use high-risk AI systems as safety components, the Commission shall take into account the requirements set out in Chapter III, Section 2, of that Regulation.

Or. fr

Amendment 659

Laurent Castillo, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain, Valérie Deloge, Viktória Ferenc

Proposal for a regulation

Article 2 – paragraph 1 – point 6 – point b

Regulation (EU) 2019/746

Article 6 – paragraph 4

Text proposed by the CommissionAmendment
4. A Member State may, on grounds of protection of public health, require a provider of a service, as defined Article 1(1), point (b), of Directive (EU) 2015/1535, or the provider of the service referred to in paragraph 2, to cease its activity.;4. A Member State may, on grounds of protection of public health, require a provider of a service, as defined Article 1(1), point (b), of Directive (EU) 2015/1535, or the provider of the service referred to in paragraph 2, to cease its activity when justified and proportionate on grounds of safety and public health;

Or. fr

Amendment 660

Ruggero Razza, Michele Picaro

Proposal for a regulation

Article 2 – paragraph 1 – point 7

Regulation (EU) 2017/746

Article 7 – subparagraph 2

Text proposed by the CommissionAmendment
Without prejudice to national law regarding the exercise of the medical profession, the first subparagraph shall also apply to devices used for the provision of a service referred to in Article 6(2).;Without prejudice to national law regarding the exercise of the medical profession, the first subparagraph shall also apply to devices used for the provision of a service referred to in Article 6(2). When implementing this Article, Member States shall not introduce or maintain prior monitoring or authorisation systems for the advertising of devices in order to avoid obstacles to the free movement of goods within the Union. Member States shall remain competent to act ex post, including by prohibiting or sanctioning advertising practices that do not meet the requirements set out in this Article, in accordance with Union and national law.

Or. it

Justification

This amendment aims to maintain harmonised EU rules on the advertising and declaration of IVDs, avoiding national pre-authorisation or notification systems that would fragment the internal market. A single framework reduces the red tape, upholds the application of Article 7 in the post-market phase and ensures more consistent monitoring, limiting divergent interpretations and distortions of competition.

Amendment 661

Laurent Castillo, Margarita de la Pisa Carrión, Ondřej Knotek, Marie-Luce Brasier-Clain, Valérie Deloge, Viktória Ferenc

Proposal for a regulation

Article 2 – paragraph 1 – point 8

Regulation (EU) 2017/746

Article 9 – paragraph 1 – first paragraph

Text proposed by the CommissionAmendment
Where no harmonised standards exist or where relevant harmonised standards are not sufficient, or where there is a need to address public health concerns, the Commission, after having consulted the MDCG, may, by means of implementing acts, adopt common specifications (CS) in respect of the requirements set out in this Regulation, in particular the reports and plans to be drawn up by manufacturers, the general safety and performance requirements set out in Annex I, the technical documentation set out in Annexes II and III, the conformity assessment procedures set out in Annexes IX, X and XI, the performance evaluation and PMPF set out in Annex XIII or the requirements regarding performance studies set out in Annexes XIII and XIV.;Where no harmonised standards exist or where relevant harmonised standards are not sufficient, or where there is a need to address public health concerns, the Commission, after having consulted the MDCG, notified bodies, manufacturers, healthcare professionals and patient representatives, may, by means of implementing acts, adopt common specifications (CS) in respect of the requirements set out in this Regulation, in particular the reports and plans to be drawn up by manufacturers, the general safety and performance requirements set out in Annex I, the technical documentation set out in Annexes II and III, the conformity assessment procedures set out in Annexes IX, X and XI, the performance evaluation and PMPF set out in Annex XIII or the requirements regarding performance studies set out in Annexes XIII and XIV.;

Or. fr

Amendment 662

Marie-Sophie Lanig, Angelika Niebler

Proposal for a regulation

Article 2 – paragraph 1 – point 9 – point c

Regulation (EU) 2017/746

Article 10 – paragraph 9

Text proposed by the CommissionAmendment
(c) paragraph 9 is deleted;(c) paragraph (9) is replaced by the following:
Notified Bodies shall rely on relevant results from audits or certifications carried out under internationally recognised quality management schemes, including ISO 13485 and the Medical Device Single Audit Program (MDSAP), where such results are suitable to demonstrate compliance with the quality management system requirements and GSPRs of this Regulation

Or. en

Amendment 663

Tiemo Wölken

Proposal for a regulation

Article 2 – paragraph 1 – point 9 – point d – point i

Regulation (EU) 2017/746

Article 10 – paragraph 10

Text proposed by the CommissionAmendment
When determining the official language of the Union in which the information set out in Section 20 of Annex I or other information to be provided by the manufacturer shall be made available, Member States shall consider accepting another official language of the Union in which the information is made available, taking into consideration the technical knowledge, experience, education or training of the average intended user(s).;When determining the official language of the Union in which the information set out in Section 20 of Annex I or other information to be provided by the manufacturer shall be made available, Member States shall consider accepting one or more official language of the Union in which the information is made available, taking into consideration the technical knowledge, experience, education or training of the average intended user(s).;

Or. en

Amendment 664

Tiemo Wölken

Proposal for a regulation

Article 2 – paragraph 1 – point 9 – point e

Regulation (EU) 2017/746

Article 10 – paragraph 12

Text proposed by the CommissionAmendment
(e) paragraph 12 is deleted;deleted

Or. en

Amendment 665

Tiemo Wölken

Proposal for a regulation

Article 2 – paragraph 1 – point 9 – point f

Regulation (EU) 2017/746

Article 10 – paragraph 13

Text proposed by the CommissionAmendment
(f) in paragraph 13, the third and fourth subparagraphs are deleted;deleted

Or. en

Amendment 666

Ignazio Roberto Marino

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 2 – paragraph 1 – point 9 – point f

Regulation (EU) 2017/746

Article 10 – paragraph 13

Text proposed by the CommissionAmendment
(f) in paragraph 13, the third and fourth subparagraphs are deleted;deleted

Or. en

Justification

The texts concerned here give the competent authority the obligation to facilitate patient access to documentation, where a competent authority believes the patient may be potentially injured by a certain device. These texts should be maintained to ensure continued access to information for patients.

Amendment 667

Tiemo Wölken

Proposal for a regulation

Article 2 – paragraph 1 – point 9 – point h

Regulation (EU) 2017/746

Article 10 – paragraph 15

Text proposed by the CommissionAmendment
(h) paragraph 15 is deleted;(h) paragraph 15 is replaced by the following:
'Natural or legal persons may claim compensation for damage caused by a defective device in accordance with applicable Union and national law. Manufacturers shall, in a manner that is proportionate to the risk class, type of device and the size of the enterprise, have measures in place to provide sufficient financial coverage in respect of their potential liability under Directive (EU) 2024/2853, without prejudice to more protective measures under national law;"

Or. en

Amendment 668

Tiemo Wölken

Proposal for a regulation

Article 2 – paragraph 1 – point 10 – point a

Regulation (EU) 2017/746

Article 10a – paragraphs 1, 2 and 3

Text proposed by the CommissionAmendment
The information referred to in the first subparagraph shall be provided at least six months before the anticipated interruption or discontinuation or, if this is not possible, without undue delay after the manufacturer becomes aware of the anticipated interruption or discontinuation.;1. The information referred to in the first subparagraph shall be provided at least six months before the anticipated interruption or discontinuation or, where this is not possible, immediately after becoming aware of the anticipated interruption or discontinuation.. The manufacturer shall specify the reasons for the interruption or discontinuation in the information provided to the competent authority in accordance with Annex XVI . Where the information initially provided changes, the manufacturer shall submit an updated notification without undue delay. The manufacturer shall notify the competent authority without undue delay upon the resumption of normal supply.
2. The competent authority that has received the information referred to in paragraph 1 shall, without undue delay, inform the competent authorities of the other Member States and the Commission of the anticipated interruption, discontinuation or resumption of normal supply.
3. The economic operators who have received the information from the manufacturer in accordance with paragraph 1 or from another economic operator in the supply chain shall, without undue delay, inform any other economic operators, health institutions and healthcare professionals to whom they directly supply the device of the anticipated interruption, or discontinuation or resumption of normal supply.

Or. en

Amendment 669

Kateřina Konečná

Proposal for a regulation

Article 2 – paragraph 1 – point 10 – point b

Regulation (EU) 2017/746

Article 10a – paragraph 4

Text proposed by the CommissionAmendment
4. The Commission, where necessary in cooperation with the EMA, shall set up, maintain, and manage an IT system to facilitate the reporting and information exchange regarding cases of interruption or discontinuation of the supply of devices in accordance with paragraphs 1, 2 and 3. That IT system shall be integrated in or interoperable with the European database on medical devices referred to in Article 30. It shall also enable health institutions and healthcare professionals to inform competent authorities about the unavailability or the immediate risk of unavailability of devices needed for the exercise of their professional activity.4. The Commission, where necessary in cooperation with the EMA, shall set up, maintain, and manage an IT system to facilitate the reporting and information exchange regarding cases of interruption or discontinuation of the supply of devices in accordance with paragraphs 1, 2 and 3. That IT system shall be integrated in or interoperable with the European database on medical devices referred to in Article 30. It shall also enable health institutions and healthcare professionals to inform competent authorities about the unavailability or the immediate risk of unavailability of devices needed for the exercise of their professional activity.
The new IT system with information on shortages of devices shall be publicly available. Information on this topic shall be made available in a timely manner for service providers for them to be able to adapt to the change.

Or. en

Amendment 670

András Tivadar Kulja

Proposal for a regulation

Article 2 – paragraph 1 – point 10 – point b

Regulation (EU) 2017/746

Article 10a – paragraph 4

Text proposed by the CommissionAmendment
4. The Commission, where necessary in cooperation with the EMA, shall set up, maintain, and manage an IT system to facilitate the reporting and information exchange regarding cases of interruption or discontinuation of the supply of devices in accordance with paragraphs 1, 2 and 3. That IT system shall be integrated in or interoperable with the European database on medical devices referred to in Article 30. It shall also enable health institutions and healthcare professionals to inform competent authorities about the unavailability or the immediate risk of unavailability of devices needed for the exercise of their professional activity.4. The Commission, where necessary in cooperation with the EMA, shall set up, maintain, and manage an IT system to facilitate the reporting and information exchange regarding cases of interruption or discontinuation of the supply of devices in accordance with paragraphs 1, 2 and 3. That IT system shall be integrated in or interoperable with the European database on medical devices referred to in Article 30. It shall also enable health institutions and healthcare professionals to inform competent authorities about the unavailability or the immediate risk of unavailability of devices needed for the exercise of their professional activity. Furthermore, online alerts with information about shortages shall be provided to healthcare professionals, allowing them to prepare and react to such shortages.

Or. en

Amendment 671

Ignazio Roberto Marino

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 2 – paragraph 1 – point 10 – point b

Regulation (EU) 2017/746

Article 10a – paragraph 4

Text proposed by the CommissionAmendment
4. The Commission, where necessary in cooperation with the EMA, shall set up, maintain, and manage an IT system to facilitate the reporting and information exchange regarding cases of interruption or discontinuation of the supply of devices in accordance with paragraphs 1, 2 and 3. That IT system shall be integrated in or interoperable with the European database on medical devices referred to in Article 30. It shall also enable health institutions and healthcare professionals to inform competent authorities about the unavailability or the immediate risk of unavailability of devices needed for the exercise of their professional activity.4. The Commission, where necessary in cooperation with the EMA, shall set up, maintain, and manage a publicly available IT system to facilitate the reporting and information exchange regarding cases of interruption or discontinuation of the supply of devices in accordance with paragraphs 1, 2 and 3. That IT system shall be integrated in or interoperable with the European database on medical devices referred to in Article 30. It shall also enable health institutions, patients and healthcare professionals to inform competent authorities about the unavailability or the immediate risk of unavailability of devices.

Or. en

Amendment 672

Tiemo Wölken

Proposal for a regulation

Article 2 – paragraph 1 – point 10 – point b

Regulation (EU) 2017/746

Article 10a – paragraph 5

Text proposed by the CommissionAmendment
5. The EMA, in collaboration with the Executive Steering Group on Shortages of Medical Devices (MDSSG) established by Article 21 of Regulation (EU) 2022/123 of the European Parliament and of the Council***, shall develop a methodology to identify the devices, or categories of devices, for which it is reasonably foreseeable that an interruption or discontinuation of supply could result in serious harm or a risk of serious harm to patients or public health as referred to in paragraph 1. Based on that methodology, the EMA, in collaboration with the MDSSG and in agreement with the Commission shall draw up, publish and keep up to date a list of devices, or categories of devices, to which paragraphs 1, 2 and 3 shall apply. For the purpose of this paragraph, the MDCG, representatives of manufacturers, other relevant actors in the supply chain for the medical device sector and representatives of healthcare professionals, of patients and of consumers may be consulted as necessary.5. The EMA, in collaboration with the Executive Steering Group on Shortages of Medical Devices (MDSSG) established by Article 21 of Regulation (EU) 2022/123 of the European Parliament and of the Council**, shall develop a methodology based on objective and transparent criteria to identify the devices, or categories of devices, for which it is reasonably foreseeable that an interruption or discontinuation of supply could affect the availability of devices and result in serious harm or a risk of serious harm to patients or public health as referred to in paragraph 1. Based on that methodology, the EMA, in collaboration with the MDSSG and in agreement with the Commission shall draw up, publish and keep up to date a list of devices, or categories of devices, to which paragraphs 1, 2 and 3 shall apply. For the purpose of this paragraph, the MDCG, representatives of manufacturers, other relevant actors in the supply chain for the medical device sector and representatives of healthcare professionals, of patients and of consumers shall be consulted where necessary.

Or. en

Amendment 673

Ignazio Roberto Marino

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 2 – paragraph 1 – point 10 – point b

Regulation 2017/745

Article 10a – paragraph 5

Text proposed by the CommissionAmendment
5. The EMA, in collaboration with the Executive Steering Group on Shortages of Medical Devices (MDSSG) established by Article 21 of Regulation (EU) 2022/123 of the European Parliament and of the Council***, shall develop a methodology to identify the devices, or categories of devices, for which it is reasonably foreseeable that an interruption or discontinuation of supply could result in serious harm or a risk of serious harm to patients or public health as referred to in paragraph 1. Based on that methodology, the EMA, in collaboration with the MDSSG and in agreement with the Commission shall draw up, publish and keep up to date a list of devices, or categories of devices, to which paragraphs 1, 2 and 3 shall apply. For the purpose of this paragraph, the MDCG, representatives of manufacturers, other relevant actors in the supply chain for the medical device sector and representatives of healthcare professionals, of patients and of consumers may be consulted as necessary.5. The EMA, in collaboration with the Executive Steering Group on Shortages of Medical Devices (MDSSG) established by Article 21 of Regulation (EU) 2022/123 of the European Parliament and of the Council***, shall develop a methodology to identify the devices, or categories of devices, for which it is reasonably foreseeable that an interruption or discontinuation of supply could result in serious harm or a risk of serious harm to patients or public health as referred to in paragraph 1. Based on that methodology, the EMA, in collaboration with the MDSSG and in agreement with the Commission shall draw up, publish and keep up to date a list of devices, or categories of devices, to which paragraphs 1, 2 and 3 shall apply. For the purpose of this paragraph, the MDCG, representatives of manufacturers, other relevant actors in the supply chain for the medical device sector and representatives of healthcare professionals, of patients and of consumers shall be consulted.

Or. en

Amendment 674

Tiemo Wölken

Proposal for a regulation

Article 2 – paragraph 1 – point 10 – point b

Regulation (EU) 2017/746

Article 10a – paragraph 6

Text proposed by the CommissionAmendment
The competent authorities of the Member States or the Commission may request the manufacturers of devices included in the list drawn up in accordance with paragraph 5 to provide all necessary information regarding risks and weaknesses within the supply chain which may affect the supply of such devices, including production capacity and volume of sales.The competent authorities of the Member States or the Commission may request the manufacturers of devices included in the list drawn up in accordance with paragraph 5 to provide all necessary information regarding risks and weaknesses within the supply chain which may affect the supply of such devices, including production capacity and volume of sales and measures taken or planned to mitigate any interruption or discontinuation of supply.

Or. en

Amendment 675

Marie-Sophie Lanig, Angelika Niebler

Proposal for a regulation

Article 2 – paragraph 1 – point 10 a (new)

Regulation (EU) 2017/746

Article 10a – paragraphs 1, 2 and 3

Present textAmendment
(10a) In Article 10a, paragraphs 1, 2 and 3 are replaced as follows:
Article 10aObligations in case of interruption or discontinuation of supply of certain devices1. Where a manufacturer anticipates an interruption or a discontinuation of the supply of a device, other than a custom-made device, and where it is reasonably foreseeable that such interruption or discontinuation could result in serious harm or a risk of serious harm to patients or public health in one or more Member States, the manufacturer shall inform the competent authority of the Member State where it or its authorised representative is established, as well as the economic operators, health institutions and healthcare professionals to whom it directly supplies the device, of the anticipated interruption or discontinuation.The information referred to in the first subparagraph shall, other than in exceptional circumstances, be provided at least 6 months before the anticipated interruption or discontinuation. The manufacturer shall specify the reasons for the interruption or discontinuation in the information provided to the competent authority.2. The competent authority that has received the information referred to in paragraph 1 shall, without undue delay, inform the competent authorities of the other Member States and the Commission of the anticipated interruption or discontinuation.3. The economic operators who have received the information from the manufacturer in accordance with paragraph 1 or from another economic operator in the supply chain shall, without undue delay, inform any other economic operators, health institutions and healthcare professionals to whom they directly supply the device, of the anticipated interruption or discontinuation.’"1. Where a manufacturer anticipates a discontinuation of the supply of a device, other than a custom-made device, it shall inform the competent authority of the Member State where it or its authorised representative is established by entering the discontinuation date to EUDAMED. Moreover, economic operators, health institutions and healthcare professionals to whom it directly supplies the device, shall be informed of the anticipated discontinuation without undue delay, to enable them to alert the competent authorities to the immediate risk of unavailability of devices needed for the exercise of their professional activity in accordance with paragraph 4, and to provide information to the Executive Steering Group on Shortages of Medical Devices.
2. The competent authority that has received the information referred to in paragraph 1 shall, without undue delay, inform the competent authorities of the other Member States and the Commission of the anticipated discontinuation.
3. The economic operators who have received the information from the manufacturer in accordance with paragraph 1 or from another economic operator in the supply chain shall, without undue delay, inform any other economic operators, health institutions and healthcare professionals to whom they directly supply the device, of the anticipated discontinuation."

Or. en

(2024/1860)

Amendment 676

Tiemo Wölken

Proposal for a regulation

Article 2 – paragraph 1 – point 11

Regulation (EU) 2017/746

Article 11 – paragraphs 4 and 5

Text proposed by the CommissionAmendment
(11) in Article 11, paragraphs 4 and 5 are deleted;deleted

Or. en

Amendment 677

Valentina Palmisano

on behalf of The Left Group

Proposal for a regulation

Article 2 – paragraph 1 – point 13 – point a

Regulation (EU) 2017/746

Article 15 – paragraph 1

Text proposed by the CommissionAmendment
(a) paragraph 1 is replaced by the following:deleted
‘1. Manufacturers shall have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of in vitro diagnostic medical devices.;’

Or. en

Justification

Better to maintain specifications for qualifications

Amendment 678

Tiemo Wölken

Proposal for a regulation

Article 2 – paragraph 1 – point 13 – point a

Regulation (EU) 2017/746

Article 15 – paragraph 1

Text proposed by the CommissionAmendment
1. Manufacturers shall have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of in vitro diagnostic medical devices.;1. Manufacturers shall have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of in vitro diagnostic medical devices. The requisite expertise shall be demonstrated by either of the following qualifications:
(a) a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to in vitro diagnostic medical devices;
(b) four years of professional experience in regulatory affairs or in quality management systems relating to in vitro diagnostic medical devices.

Or. en

Amendment 679

Ruggero Razza, Michele Picaro

Proposal for a regulation

Article 2 – paragraph 1 – point 13 – point a

Regulation (EU) 2017/746

Article 15 – paragraph 1

Text proposed by the CommissionAmendment
1. Manufacturers shall have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of in vitro diagnostic medical devices.;1. Manufacturers shall have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of in vitro diagnostic medical devices.
The requisite expertise shall be demonstrated by either of the following qualifications:
(a) a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices;
(b) four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.

Or. it

Justification

Maintaining the training and experience requirements of the PRRC laid down in the MDR and IVDR is essential to ensure their competence, oversight and accountability. Removing them would not simplify the framework but would increase the risk of non-compliance and national divergences, especially in Italy, where the PRRC is subject to specific responsibilities and penalties. Flexibility for SMEs should not undermine the basic qualification requirements.

Amendment 680

Tiemo Wölken

Proposal for a regulation

Article 2 – paragraph 1 – point 13 – point b

Regulation (EU) 2017/746

Article 15 – paragraph 2

Text proposed by the CommissionAmendment
Micro and small enterprises within the meaning of Commission Recommendation 2003/361/EC**** shall not be required to have the person responsible for regulatory compliance within their organisation but shall have such person at their disposal.Micro and small enterprises within the meaning of Commission Recommendation 2003/361/EC**** shall not be required to have the person responsible for regulatory compliance within their organisation but shall have such person at their disposal at all times.

Or. en

Amendment 681

Valentina Palmisano

on behalf of The Left Group

Proposal for a regulation

Article 2 – paragraph 1 – point 13 – point d

Regulation (EU) 2017/746

Article 15 – paragraph 6

Text proposed by the CommissionAmendment
(d) paragraph 6 is replaced by the following:deleted
‘6. Authorised representatives shall have permanently and continuously at their disposal at least one person responsible for regulatory compliance who possesses the requisite expertise regarding the regulatory requirements for in vitro diagnostic medical devices in the Union.;’

Or. en

Justification

Better to specify qualifications

Amendment 682

Tiemo Wölken

Proposal for a regulation

Article 2 – paragraph 1 – point 13 – point d

Regulation (EU) 2017/746

Article 15 – paragraph 6

Text proposed by the CommissionAmendment
6. Authorised representatives shall have permanently and continuously at their disposal at least one person responsible for regulatory compliance who possesses the requisite expertise regarding the regulatory requirements for in vitro diagnostic medical devices in the Union.;6. Authorised representatives shall have permanently and continuously at their disposal at least one person responsible for regulatory compliance who possesses the requisite expertise regarding the regulatory requirements for in vitro diagnostic medical devices in the Union. The requisite expertise shall be demonstrated by either of the following qualifications:
(a) a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to in vitro diagnostic medical devices;
(b) four years of professional experience in regulatory affairs or in quality management systems relating to in vitro diagnostic medical devices.

Or. en

Amendment 683

Tiemo Wölken

Proposal for a regulation

Article 2 – paragraph 1 – point 14 – point b

Regulation (EU) 2017/746

Article 16 – paragraph 4

Text proposed by the CommissionAmendment
(b) paragraph 4 is deleted;(b) paragraph 4 replaced by the following:
' At least 28 days prior to making the relabelled, refurbished or repackaged device available on the market, distributors or importers carrying out any of the activities referred to in points (a) and (b) of paragraph 2 shall inform the manufacturer and the competent authority of the Member State in which they intend to make the device available of their intention to place the relabelled, refurbished or repackaged device on the market. Upon request by the competent authority, the distributor or importer shall provide a sample or a mock-up of the relabelled or repackaged device, including any translated label and instructions for use. Within the same period of 28 days, the competent authority may, where it considers it necessary, require the distributor or importer to submit a certificate, issued by a notified body designated for the type of devices subject to the activities referred to in points (a) and (b) of paragraph 2, attesting that the quality management system of the distributor or importer complies with the requirements laid down in paragraph 3.'

Or. en

Amendment 684

Ruggero Razza, Michele Picaro

Proposal for a regulation

Article 2 – paragraph 1 – point 14 – point b

Regulation (EU) 2017/746

Article 16 – paragraph 4

Text proposed by the CommissionAmendment
(b) paragraph 4 is deleted;(b) paragraph 4 is amended as follows:
4. At least 28 days prior to making the relabelled or repackaged device available on the market, distributors or importers carrying out any of the activities mentioned in points (a) and (b) of paragraph 2 shall inform the manufacturer of their intention to make the relabelled or repackaged device available and, upon request, shall provide the manufacturer with a sample or mock-up of the relabelled or repackaged device, including any translated label and instructions for use.

Or. it

Justification

Transparency requirements for those who relabel or repackage medical devices should be maintained. Even when these activities do not give the operator the status of manufacturer, the original manufacturer should be able to identify and monitor changes affecting traceability, performance and post-market surveillance. Timely information is essential to ensuring supply chain integrity and patient safety.

Amendment 685

Adam Jarubas

Proposal for a regulation

Article 2 – paragraph 1 – point 14 – point b

Regulation (EU) 2017/746

Article 16 – paragraph 4

Text proposed by the CommissionAmendment
(b) paragraph 4 is deleted;(b) paragraph 4 is amended as follows;
‘
4. At least 28 days prior to making the relabelled or repackaged device available on the market, distributors or importers carrying out any of the activities mentioned in points (a) and (b) of paragraph 2 shall inform the manufacturer of their intention to make the relabelled or repackaged device available and, upon request, shall provide the manufacturer with a sample or mockup of the relabelled or repackaged device, including any translated label and instructions for use.
’

Or. en

Justification

Thepurpose of the amendment is to align the IVDR with the approach proposed forArticle 16 of the MDR. It is intended to maintain manufacturer oversight insituations where importers or distributors relabel or repackage devices, sothat manufacturers continue to be informed of any changes that could affect thedevice, its labelling or the instructions for use. This contributes totraceability, supports effective vigilance and post-market surveillance,enables timely corrective measures where needed, and helps safeguard theintegrity and safe use of devices across the supply chain.

Amendment 686

Tiemo Wölken

Proposal for a regulation

Article 2 – paragraph 1 – point 15 a (new)

Regulation (EU) 2017/746

Article 18 – paragraph 5

Present textAmendment
(15a) In Article 18, paragraph 5 is replaced by the following:
5. Where applicable, the CE marking shall be followed by the identification number of the notified body responsible for the conformity assessment procedures set out in Article 48. The identification number shall also be indicated in any promotional material which mentions that a device fulfils the requirements for CE marking."5. The identification number of the notified body responsible for the conformity assessment procedures set out in Article 48 shall be part of the information to be submitted by the manufacturer to the UDI database in accordance with Article 26.. The identification number shall also be indicated in any promotional material which mentions that a device fulfils the requirements for CE marking."

Or. en

(Regulation (EU) 2017/746)

Amendment 687

Laurent Castillo, Marie-Luce Brasier-Clain, Valérie Deloge, Viktória Ferenc

Proposal for a regulation

Article 2 – paragraph 1 – point 18 a (new)

Regulation (EU) 2017/746

Article 25

Text proposed by the CommissionAmendment
(18a) Article 25 is amended as follows:
UDI database
The Commission, after consulting the MDCG, shall set up and manage a UDI database in accordance with the conditions and detailed arrangements provided for in Article 28 of Regulation (EU) 2017/745. The UDI database shall be accessible to the public in all official languages of the Union and shall respect the principle of business secrecy.

Or. fr

Amendment 688

Tiemo Wölken

Proposal for a regulation

Article 2 – paragraph 1 – point 19

Regulation (EU) 2017/746

Article 26 – paragraph 1

Text proposed by the CommissionAmendment
1. Before placing a device, other than a device for performance study, on the market, the manufacturer shall provide the Basic UDI-DI to the UDI database together with the other core data elements referred to in Part B of Annex VI related to that device, as applicable. The manufacturer shall keep up to date the information provided to the UDI database.1. Before placing a device, other than a device for performance study, on the market, the manufacturer shall provide the Basic UDI-DI to the UDI database together with the other core data elements referred to in Part B of Annex VI related to that device, as applicable. The manufacturer shall keep up to date the information provided to the UDI database and introduce any changes without undue delay and no later than one months after the change occurs.

Or. en

Amendment 689

Laurence Trochu

Proposal for a regulation

Article 2 – paragraph 1 – point 20

Regulation (EU) 2017/746

Article 27 – paragraph 2

Text proposed by the CommissionAmendment
Where national distributor databases require information on devices, such databases shall allow for the retrieval of the device information from the electronic systems referred to in Article 30(2), points (a) and (b).;Where national distributor databases require information on devices, such databases shall allow for the retrieval of the device information from the electronic systems referred to in Article 30(2), points (a) and (b), although it may be necessary to allow a reasonable period of time for implementation.;

Or. fr

Amendment 690

Laurent Castillo, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain, Valérie Deloge

Proposal for a regulation

Article 2 – paragraph 1 – point 21 – point b

Regulation (EU) 2017/746

Article 28 – paragraph 2

Text proposed by the CommissionAmendment
2. Without undue delay, the competent authority shall verify the data entered pursuant to paragraph 1, obtain a single registration number (‘SRN’) from the electronic system referred to in Article 27 and issue it to the manufacturer, the authorised representative or the importer’;2. Within 10 days of receipt of the complete dossier, the competent authority shall verify the data entered pursuant to paragraph 1, obtain a single registration number (‘SRN’) from the electronic system referred to in Article 27 and issue it to the manufacturer, the authorised representative or the importer’;

Or. fr

Amendment 691

Ruggero Razza, Michele Picaro

Proposal for a regulation

Article 2 – paragraph 1 – point 22 – point a

Regulation (EU) 2017/746

Article 29 – paragraph 1 – subparagraph 2

Text proposed by the CommissionAmendment
The summary of safety and performance shall be written in a way that is clear to the intended user.deleted

Or. it

Amendment 692

Tiemo Wölken

Proposal for a regulation

Article 2 – paragraph 1 – point 22 – point a

Regulation (EU) 2017/746

Article 29 – paragraph 1 – subparagraph 2

Text proposed by the CommissionAmendment
The summary of safety and performance shall be written in a way that is clear to the intended user.The summary of safety and clinical performance shall be written in a way that is clear and understandable to the intended user and, where relevant to the patient as a lay person, and shall be made available to the public via Eudamed.

Or. en

Amendment 693

Ruggero Razza, Michele Picaro

Proposal for a regulation

Article 2 – paragraph 1 – point 22 – point a

Regulation (EU) 2017/746

Article 29 – paragraph 1 – subparagraph 3

Text proposed by the CommissionAmendment
The draft of the summary of safety and performance shall be part of the documentation to be submitted to the notified body involved in the conformity assessment pursuant to Article 48. The manufacturer shall ensure that the summary of safety and performance is available to the public in Eudamed and shall mention on the label or instructions for use where the summary is available. ;The draft of the summary of safety and performance shall be part of the documentation to be submitted to the notified body involved in the conformity assessment pursuant to Article 48. Only the English language version of the summary shall be subject to validation by the notified body. The manufacturer shall ensure that the summary of safety and performance is available to the public in Eudamed and shall mention on the label or instructions for use where the summary is available. By default, only the English language version of the summary of safety and performance shall be provided. Translations into the other languages accepted in the Member States shall be provided upon request within reasonable time.

Or. it

Justification

The aim is to reduce the financial and administrative burden of translating SSCPs (summaries of safety and clinical performance) into all EU languages, limiting mandatory translations to actual demand. Initially providing the SSCP in English would ease the burden on both manufacturers and the notified bodies, without reducing the safety requirements of the device.

Amendment 694

Laurence Trochu

Proposal for a regulation

Article 2 – paragraph 1 – point 23

Regulation 2017/746

Article 30 – paragraph 2

Text proposed by the CommissionAmendment
By way of derogation from the first subparagraph, the Commission may decide that one or more of the electronic systems referred to in that subparagraph are not to be included in Eudamed. In that case, the Commission shall ensure that the electronic system is interoperable with Eudamed.;By way of derogation from the first subparagraph, the Commission may be of the opinion that one or more of the electronic systems referred to in that subparagraph are not to be included in Eudamed. In that case, the Commission shall contact the Member States concerned to clarify the conditions for the interoperability of the electronic system with Eudamed.;

Or. fr

Amendment 695

Laurence Trochu

Proposal for a regulation

Article 2 – paragraph 1 – point 25 – point b

Regulation (EU) 2017/746

Article 32 – paragraph 4

Text proposed by the CommissionAmendment
(b) the following paragraph 4 is added:deleted
‘4. The Commission is empowered to adopt delegated acts in accordance with Article 108 to amend Annex VII in order to adapt to technical and scientific progress regarding conformity assessment in the field of in vitro diagnostic medical devices, including developments at international level.’;

Or. fr

Amendment 696

Laurent Castillo, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain, Valérie Deloge, Viktória Ferenc

Proposal for a regulation

Article 2 – paragraph 1 – point 25 – point b

Regulation (EU) 2017/746

Article 32 – paragraph 4

Text proposed by the CommissionAmendment
4. The Commission is empowered to adopt delegated acts in accordance with Article 108 to amend Annex VII in order to adapt to technical and scientific progress regarding conformity assessment in the field of in vitro diagnostic medical devices, including developments at international level.;4. The Commission is empowered to adopt delegated acts in accordance with Article 108 to amend Annex VII in order to adapt to technical and scientific progress regarding conformity assessment in the field of in vitro diagnostic medical devices, including developments at international level. Before adopting such delegated acts, the Commission shall consult the MDCG, notified bodies and manufacturers’ representatives.;

Or. fr

Amendment 697

Laurent Castillo, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain, Valérie Deloge, Viktória Ferenc

Proposal for a regulation

Article 2 – paragraph 1 – point 27 – point d

Regulation (EU) 2017/746

Article 47 – paragraph 7

Text proposed by the CommissionAmendment
7. The Commission is empowered to adopt delegated acts in accordance with Article 108 to amend Annex VIII in order to adapt it to technical or scientific progress or to take into account developments regarding classification of devices at international level.;7. The Commission is empowered to adopt delegated acts in accordance with Article 108 to amend Annex VIII in order to adapt it to technical or scientific progress or to take into account developments regarding classification of devices at international level. The Commission shall consult the MDCG and relevant stakeholders before adopting delegated acts under this paragraph.;

Or. fr

Amendment 698

Laurent Castillo, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain, Valérie Deloge, Viktória Ferenc

Proposal for a regulation

Article 2 – paragraph 1 – point 29 – point j

Regulation (EU) 2017/746

Article 48 – paragraph 13 – point b

Text proposed by the CommissionAmendment
(b) the modalities of unannounced on-site audits and sample tests to be conducted by notified bodies in accordance with Section 3.4 of Annex IX, taking into account the risk-class and the type of device;(b) the modalities of unannounced on-site audits and sample tests to be conducted by notified bodies in accordance with Section 3.4 of Annex IX, taking into account the risk-class and the type of device. The frequency of unannounced audits shall be proportionate to the risk profile of the manufacturer and the conformity history of the device;

Or. fr

Amendment 699

Andreas Glück, Stine Bosse, Billy Kelleher

Proposal for a regulation

Article 2 – paragraph 1 – point 29 – point j

Regulation (EU) 2017/745

Article 48 – paragraph 13 – point e

Text proposed by the CommissionAmendment
(e) the modalities of the conformity assessment procedures regarding breakthrough devices and orphan devices set out in Article 48a.(e) the modalities of the conformity assessment procedures regarding breakthrough devices, orphan devices, and paediatric devices set out in Article 48a.

Or. en

Amendment 700

Laurence Trochu

Proposal for a regulation

Article 2 – paragraph 1 – point 29 – point k

Regulation (EU) 2017/746

Article 48 – paragraph 14

Text proposed by the CommissionAmendment
(k) the following paragraph 14 is added:deleted
‘14. The Commission is empowered to adopt delegated acts in accordance with Article 108 to amend Annexes IX, X and XI in order to adapt those Annexes to technical or scientific progress or to developments regarding conformity assessment of devices at international level and to take into account the needs of particular devices in view of their special characteristics.’;

Or. fr

Amendment 701

Laurence Trochu

Proposal for a regulation

Article 2 – paragraph 1 – point 29 a (new)

Regulation (EU) 2017/746

Article 48 – paragraph 1

Present textAmendment
(29a) paragraph 1 is replaced by the following:
1. Prior to placing a device on the market, manufacturers shall undertake an assessment of the conformity of that device, in accordance with the applicable conformity assessment procedures set out in Annexes IX to XI.‘1. Prior to placing a device on the market, manufacturers shall undertake an assessment of the conformity of that device, in accordance with the applicable conformity assessment procedures set out in Annexes IX to XI.
This conformity assessment shall also cover any ethical dimensions of devices such as pre-implantation diagnostic devices. It shall focus, in particular, on the proportionality of the risks and benefits and reference to the ethical aspect in specific documentation intended for the patient.’

Or. fr

(Regulation (EU) 2017/746, Article 48 - paragraph 1)

Amendment 702

Andreas Glück, Stine Bosse, Billy Kelleher

Proposal for a regulation

Article 2 – paragraph 1 – point 30

Regulation (EU) 2017/746

Article 48a – paragraph 1

Text proposed by the CommissionAmendment
1. For the conformity assessment of breakthrough devices and orphan devices, for which a notified body is involved in the conformity assessment, the procedures laid down in Article 48 shall apply subject to the specific arrangements set out in this Article.1. For the conformity assessment of breakthrough devices, orphan devices, and paediatric devices, for which a notified body is involved in the conformity assessment, the procedures laid down in Article 48 shall apply subject to the specific arrangements set out in this Article.

Or. en

Justification

Not all paediatric devices qualify as orphan or breakthrough devices, yet they face the same challenges: small patient populations, limited clinical data, high development costs and low commercial viability. Explicit inclusion ensures paediatric devices benefit from prioritised conformity assessment and rolling review, preventing manufacturers from abandoning devices for children due to disproportionate regulatory burden.

Amendment 703

Andreas Glück, Stine Bosse, Billy Kelleher

Proposal for a regulation

Article 2 – paragraph 1 – point 30

Regulation (EU) 2017/746

Article 48a – paragraph 2

Text proposed by the CommissionAmendment
2. A device shall be considered a breakthrough device if it meets the following criteria:deleted
(a) the device is expected to introduce in the Union a high degree of novelty with respect to the device technology or the related clinical procedure or the application of the device in clinical practice;
(b) the device is expected to provide a significant positive clinical impact on patient or public health, for a life-threatening or irreversibly debilitating disease or condition, by either of the following:
(i) offering a significant positive clinical or health impact compared to available alternatives and the state of the art;
(ii) fulfilling an unmet medical need where there is an absence or insufficiency of available alternative options for that purpose.

Or. en

Amendment 704

Tiemo Wölken

Proposal for a regulation

Article 2 – paragraph 1 – point 30

Regulation (EU) 2017/746

Article 48a – paragraph 2

Text proposed by the CommissionAmendment
2. A device shall be considered a breakthrough device if it meets the following criteria:2. A device shall be considered a breakthrough device if it meets all of the following criteria:

Or. en

Amendment 705

Tiemo Wölken

Proposal for a regulation

Article 2 – paragraph 1 – point 30

Regulation (EU) 2017/746

Article 48a – paragraph 2 –point b – point i

Text proposed by the CommissionAmendment
(i) offering a significant positive clinical or health impact compared to available alternatives and the state of the art;(i) offering a significant positive clinical benefit or health impact compared to available alternatives and the state of the art;

Or. en

Amendment 706

Tiemo Wölken

Proposal for a regulation

Article 2 – paragraph 1 – point 30

Regulation (EU) 2017/746

Article 48a – paragraph 2 – b – point ii

Text proposed by the CommissionAmendment
(ii) fulfilling an unmet medical need where there is an absence or insufficiency of available alternative options for that purpose.(ii) fulfilling an unmet medical need where there is an absence or insufficiency of available alternative options for that purpose or where the available alternatives do not adequately address the medical needs of the target patient population.

Or. en

Amendment 707

Valentina Palmisano

on behalf of The Left Group

Proposal for a regulation

Article 2 – paragraph 1 – point 30

Regulation (EU) 2017/746

Article 48a – paragraph 2 – point ba (new)

Text proposed by the CommissionAmendment
(ba) It has already undergone initial testing, the assessment of which indicates that the clinical benefits of assigning it to the category of breakthrough devices outweigh the risks.

Or. en

Amendment 708

Andreas Glück, Stine Bosse, Billy Kelleher

Proposal for a regulation

Article 2 – paragraph 1 – point 30

Regulation (EU) 2017/746

Article 48a – paragraph 3

Text proposed by the CommissionAmendment
3. A device shall be considered an orphan device if it meets the following criteria:deleted
(a) the device is intended to provide information on a disease or condition that presents in not more than 12 000 individuals in the Union per year;
(b) at least one of the following criteria is met:
(i) there are insufficient available alternatives;
(ii) the device is expected to provide a clinical benefit compared to available alternatives or the state of the art.

Or. en

Amendment 709

Aurelijus Veryga

Proposal for a regulation

Article 2 – paragraph 1 – point 30

Regulation (EU) 2017/746

Article 48a – paragraph 3 – point a

Text proposed by the CommissionAmendment
(a) the device is intended to provide information on a disease or condition that presents in not more than 12 000 individuals in the Union per year;(a) the device is intended to provide medical information to benefit patient populations defined by rare biomarkers and/or clinical indications with a prevalence of not more than five in 10 thousand persons, as defined by EU Regulation 141/2000 on orphan medicinal products

Or. en

Amendment 710

Tiemo Wölken

Proposal for a regulation

Article 2 – paragraph 1 – point 30

Regulation (EU) 2017/746

Article 48a –paragraph 3 – point b – point ii

Text proposed by the CommissionAmendment
(ii) the device is expected to provide a clinical benefit compared to available alternatives or the state of the art.(ii) the device is expected to provide a clinical benefit compared to available alternatives or the state of the art or where the available alternatives do not adequately address the medical needs of the target patient population

Or. en

Amendment 711

Tiemo Wölken

Proposal for a regulation

Article 2 – paragraph 1 – point 30

Regulation (EU) 2017/746

Article 48a – paragraph 5

Text proposed by the CommissionAmendment
5. Where the opinion of the expert panel confirms the fulfilment of the criteria set out in paragraph 2 or 3 of this Article, the manufacturer of a breakthrough device or of an orphan device, as applicable, may request advice from the expert panels referred to in Article 106 of Regulation (EU) 2017/745 regarding its performance evaluation strategy and appropriate analytical or clinical performance data for the performance evaluation of the device.5. Where the opinion of the expert panel confirms the fulfilment of the criteria set out in paragraph 2 or 3 of this Article, the manufacturer of a breakthrough device or of an orphan device, as applicable, may request advice from the expert panels referred to in Article 106 of Regulation (EU) 2017/745 regarding its performance evaluation strategy and appropriate analytical or clinical performance data for the performance evaluation of the device, including scientific and regulatory advice throughout the development of the device. Where appropriate, the expert panel shall coordinate with the notified body concerned in order to facilitate a coordinated approach to the conformity assessment of the device.

Or. en

Amendment 712

Aurelijus Veryga

Proposal for a regulation

Article 2 – paragraph 1 – point 30

Regulation (EU) 2017/746

Article 48a – paragraph 5

Text proposed by the CommissionAmendment
5. Where the opinion of the expert panel confirms the fulfilment of the criteria set out in paragraph 2 or 3 of this Article, the manufacturer of a breakthrough device or of an orphan device, as applicable, may request advice from the expert panels referred to in Article 106 of Regulation (EU) 2017/745 regarding its performance evaluation strategy and appropriate analytical or clinical performance data for the performance evaluation of the device.5. Where the opinion of the expert panel confirms the fulfilment of the criteria set out in paragraph 2 or 3 of this Article, the manufacturer of a breakthrough device or of an orphan device and the sponsor of the clinical trial(s), as applicable, may request advice from the expert panels referred to in Article 106 of Regulation (EU) 2017/745 regarding its performance evaluation strategy and appropriate analytical or clinical performance data for the performance evaluation of the device.

Or. en

Amendment 713

Andreas Glück, Stine Bosse, Billy Kelleher

Proposal for a regulation

Article 2 – paragraph 1 – point 30

Regulation (EU) 2017/746

Article 48a – paragraph 5

Text proposed by the CommissionAmendment
5. Where the opinion of the expert panel confirms the fulfilment of the criteria set out in paragraph 2 or 3 of this Article, the manufacturer of a breakthrough device or of an orphan device, as applicable, may request advice from the expert panels referred to in Article 106 of Regulation (EU) 2017/745 regarding its performance evaluation strategy and appropriate analytical or clinical performance data for the performance evaluation of the device.5. Where the opinion of the expert panel confirms the fulfilment of the criteria set out in paragraph 2 or 3 of this Article, the manufacturer of a breakthrough device, an orphan device, or a paediatric device as applicable, may request advice from the expert panels referred to in Article 106 of Regulation (EU) 2017/745 regarding its performance evaluation strategy and appropriate analytical or clinical performance data for the performance evaluation of the device.

Or. en

Justification

Not all paediatric devices qualify as orphan or breakthrough devices, yet they face the same challenges: small patient populations, limited clinical data, high development costs and low commercial viability. Explicit inclusion ensures paediatric devices benefit from prioritised conformity assessment and rolling review, preventing manufacturers from abandoning devices for children due to disproportionate regulatory burden.

Amendment 714

Tiemo Wölken

Proposal for a regulation

Article 2 – paragraph 1 – point 30

Regulation (EU) 2017/746

Article 48a – paragraph 6 – subparagraph 1

Text proposed by the CommissionAmendment
For a confirmed breakthrough device or an orphan device, as applicable, the notified body involved in the conformity assessment procedure set out in Article 48 shall prioritise the conformity assessment and apply, where appropriate, a rolling review with a view to reduce assessment timelines.For a confirmed breakthrough device or an orphan device, as applicable, the notified body involved in the conformity assessment procedure set out in Article 48 shall prioritise the conformity assessment and apply, where appropriate, a rolling review with a view to reduce assessment timelines, while ensuring that the conformity assessment remains scientifically robust and that the applicable requirements of this Regulation continue to be fulfilled.

Or. en

Amendment 715

Andreas Glück, Stine Bosse, Billy Kelleher

Proposal for a regulation

Article 2 – paragraph 1 – point 30

Regulation (EU) 2017/746

Article 48a – paragraph 6 – subparagraph 1

Text proposed by the CommissionAmendment
For a confirmed breakthrough device or an orphan device, as applicable, the notified body involved in the conformity assessment procedure set out in Article 48 shall prioritise the conformity assessment and apply, where appropriate, a rolling review with a view to reduce assessment timelines.For a confirmed breakthrough device, an orphan device, or a paediatric device, as applicable, the notified body involved in the conformity assessment procedure set out in Article 48 shall prioritise the conformity assessment and apply, where appropriate, a rolling review with a view to reduce assessment timelines.

Or. en

Amendment 716

Aurelijus Veryga

Proposal for a regulation

Article 2 – paragraph 1 – point 30

Regulation (EU) 2017/746

Article 48a – paragraph 6 – subparagraph 2

Text proposed by the CommissionAmendment
The notified body shall give due consideration to an opinion or advice provided by the expert panel in accordance with paragraph 4 or 5 and, where it does not follow such opinion or advice, it shall provide duly justified reasons. The notified body may ask the expert panel to clarify the opinion it has provided.The notified body shall be able to participate in the provision of joint advice set out in paragraph 5 and give due consideration to an opinion or advice provided by the expert panel in accordance with paragraph 4 or 5 and, where it does not follow such opinion or advice, it shall provide duly justified reasons. The notified body may ask the expert panel to clarify the opinion it has provided.

Or. en

Amendment 717

Aurelijus Veryga

Proposal for a regulation

Article 2 – paragraph 1 – point 30

Regulation (EU) 2017/746

Article 48a – paragraph 6a (new)

Text proposed by the CommissionAmendment
6a. For companion diagnostics and drug device products, the notified body involved in the conformity assessment procedure set out in Article 48 shall prioritise the conformity assessment and apply, where appropriate, a rolling review with a view to reduce assessment timelines to align with the accelerated review timelines for the corresponding medicinal product (e.g. centralized MAA under accelerated assessment). The notified body shall in this case provide expedited approval timelines to avoid a lack of patient access to the corresponding medicinal product.

Or. en

Amendment 718

Valentina Palmisano

on behalf of The Left Group

Proposal for a regulation

Article 2 – paragraph 1 – point 30

Regulation (EU) 2017/746

Article 48a – paragraph 7

Text proposed by the CommissionAmendment
The notified body shall issue a certificate pursuant to Article 51 where the pre-market clinical evidence, even if based on limited clinical performance data, is deemed adequate, provided that either of the following conditions is fulfilled:The notified body shall issue a certificate pursuant to Article 51 where the pre-market clinical evidence is deemed adequate, provided that all of the following conditions are fulfilled:

Or. en

Amendment 719

Tiemo Wölken

Proposal for a regulation

Article 2 – paragraph 1 – point 30

Regulation (EU) 2017/746

Article 48a – paragraph 7 – point b

Text proposed by the CommissionAmendment
(b) the benefit-risk ratio of the device is favourable and the manufacturer commits to providing additional data from post-market performance follow-up activities.(b) the benefit-risk ratio of the device is favourable and the manufacturer commits to providing additional data from post-market performance follow-up activities, in accordance with a post-market clinical follow-up plan containing appropriate milestones and timelines for the generation of additional clinical evidence.

Or. en

Amendment 720

Tiemo Wölken

Proposal for a regulation

Article 2 – paragraph 1 – point 30

Regulation (EU) 2017/746

Article 48a – paragraph 7 – subparagraph 2

Text proposed by the CommissionAmendment
Where appropriate, the notified body shall limit the validity of the certificate and specify any conditions for or limitations to the certificate’s validity in accordance with Article 51, such as specific post-market performance follow-up activities to be conducted within a specified period of time.The notified body shall limit the validity of the initial certificate to a maximum of five years and specify any conditions for or limitations to the certificate’s validity in accordance with Article 51, such as specific post-market performance follow-up activities to be conducted within a specified period of time. Where the manufacturer fails to fulfil the post-market clinical follow-up obligations attached to the certificate within the specified timeframe, the certificate shall not be renewed by the notified body. The notified body shall only extend the validity of the certificate, following an assessment performed in accordance with Annex VII, Section 4.11.

Or. en

Amendment 721

Viktória Ferenc, Ondřej Knotek

Proposal for a regulation

Article 2 – paragraph 1 – point 30

Regulation (EU) 2017/746

Article 48a – paragraph 7 – subparagraph 2

Text proposed by the CommissionAmendment
Where appropriate, the notified body shall limit the validity of the certificate and specify any conditions for or limitations to the certificate’s validity in accordance with Article 51, such as specific post-market performance follow-up activities to be conducted within a specified period of time.Where appropriate, the validity of the initial certificate shall be limited to a maximum of five years. The notified body shall specify any conditions for the certificate’s validity in accordance with Article 51, including, where necessary, specific post-market clinical follow-up activities within a defined timeframe. The certificate may be renewed where the manufacturer has demonstrated compliance with the applicable post-market clinical follow-up requirements.

Or. en

Justification

The proposed amendment facilitates earlier access for breakthrough, orphan and niche devices while ensuring that if, for example, limited clinical data is provided, this is balanced by clear safeguards including a time-limited initial certificate and binding post-market clinical follow-up activities

Amendment 722

Aurelijus Veryga

Proposal for a regulation

Article 2 – paragraph 1 – point 30

Regulation (EU) 2017/746

Article 48a – paragraph 7 – subparagraph 2

Text proposed by the CommissionAmendment
Where appropriate, the notified body shall limit the validity of the certificate and specify any conditions for or limitations to the certificate’s validity in accordance with Article 51, such as specific post-market performance follow-up activities to be conducted within a specified period of time.Where appropriate, the validity of the initial certificate shall be limited to a maximum of five years. The notified body shall specify any conditions for the certificate’s validity in accordance with Article 51, including, where necessary, specific post-market clinical follow-up activities within a defined timeframe. The certificate may be renewed where the manufacturer has demonstrated compliance with the applicable post-market clinical follow-up requirements.

Or. en

Amendment 723

Valentina Palmisano

on behalf of The Left Group

Proposal for a regulation

Article 2 – paragraph 1 – point 30

Regulation (EU) 2017/746

Article 48a – paragraph 7 – subparagraph 2

Text proposed by the CommissionAmendment
Where appropriate, the notified body shall limit the validity of the certificate and specify any conditions for or limitations to the certificate’s validity in accordance with Article 51, such as specific post-market performance follow-up activities to be conducted within a specified period of time.For breakthrough devices and where appropriate for orphan devices, the notified body shall limit the time of validity for the certificate and specify any conditions for or limitations to the certificate’s validity in accordance with Article 56, such as a requirement for the manufacturer to conduct specific post-market clinical follow-up activities within a specified period of time.

Or. en

Amendment 724

Andreas Glück, Stine Bosse, Billy Kelleher

Proposal for a regulation

Article 2 – paragraph 1 – point 30

Regulation (EU) 2017/746

Article 48a – paragraph 8

Text proposed by the CommissionAmendment
8. The Commission is empowered to adopt delegated acts in accordance with Article 108 in order to amend this Article to adapt to technical and scientific progress and to take into account developments regarding conformity assessment of breakthrough devices or orphan devices at international level.8. The Commission is empowered to adopt delegated acts in accordance with Article 108 in order to amend this Article to adapt to technical and scientific progress and to take into account developments regarding conformity assessment of breakthrough devices, orphan devices or paediatric devices at international level.

Or. en

Amendment 725

Tiemo Wölken

Proposal for a regulation

Article 2 – paragraph 1 – point 30

Regulation (EU) 2017/746

Article 48a – paragraph 9

Text proposed by the CommissionAmendment
9. The Commission may, by means of implementing acts, lay down further details of the procedure for the conformity assessment of breakthrough devices or orphan devices set out in this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3).9. The Commission may, by means of implementing acts, lay down further details of the procedure for the conformity assessment of breakthrough devices or orphan devices set out in this Article, including arrangements for rolling review, interactions with expert panels and procedural timelines for prioritized assessments.Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3).

Or. en

Amendment 726

Aurelijus Veryga

Proposal for a regulation

Article 2 – paragraph 1 – point 30

Regulation (EU) 2017/746

Article 48a – paragraph 9

Text proposed by the CommissionAmendment
9. The Commission may, by means of implementing acts, lay down further details of the procedure for the conformity assessment of breakthrough devices or orphan devices set out in this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3).9. The Commission may, by means of implementing acts, lay down further details of the procedure for the conformity assessment of breakthrough devices, orphan devices or niche devices set out in this Article, including mechanisms for prioritisation and rolling review by notified bodies.Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3).

Or. en

Amendment 727

Andreas Glück, Stine Bosse, Billy Kelleher

Proposal for a regulation

Article 2 – paragraph 1 – point 30

Regulation (EU) 2017/746

Article 48a – paragraph 9

Text proposed by the CommissionAmendment
9. The Commission may, by means of implementing acts, lay down further details of the procedure for the conformity assessment of breakthrough devices or orphan devices set out in this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3).9. The Commission may, by means of implementing acts, lay down further details of the procedure for the conformity assessment of breakthrough devices, orphan devices or paediatric devices set out in this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3).

Or. en

Justification

Not all paediatric devices qualify as orphan or breakthrough devices, yet they face the same challenges: small patient populations, limited clinical data, high development costs and low commercial viability. Explicit inclusion ensures paediatric devices benefit from prioritised conformity assessment and rolling review, preventing manufacturers from abandoning devices for children due to disproportionate regulatory burden.

Amendment 728

Laurent Castillo, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain, Valérie Deloge

Proposal for a regulation

Article 2 – paragraph 1 – point 32

Regulation (EU) 2017/746

Article 50 – paragraph 3

Text proposed by the CommissionAmendment
3. The notified body shall give utmost consideration to the advice of the expert panel or the EU reference laboratory, as applicable, and, where needed, take any appropriate measures, including those referred to in Article 51(3) and (4).;3. The notified body shall give utmost consideration to the advice of the expert panel or the EU reference laboratory, as applicable, and, where needed, take any appropriate measures, including those referred to in Article 51(3) and (4). If the notified body does not follow the advice of the expert panel or the EU reference laboratory, it shall provide a reasoned justification for its decision.

Or. fr

Amendment 729

Valentina Palmisano

on behalf of The Left Group

Proposal for a regulation

Article 2 – paragraph 1 – point 33 – point a

Regulation (EU) 2017/746

Article 51 – paragraph 2

Text proposed by the CommissionAmendment
2. The validity of certificates shall not be limited in time, unless in exceptional cases where the notified body considers it necessary to limit the period of validity based on duly justified grounds. In those cases, the notified body shall indicate the period of validity on the certificate. If the period of validity of the certificate is limited, on application by the manufacturer, the notified body may, following an assessment performed in accordance with Annex VII, Section 4.11, extend the validity of the certificate. Any supplement to a certificate shall remain valid as long as the certificate which it supplements is valid.;deleted

Or. en

Amendment 730

Kateřina Konečná

Proposal for a regulation

Article 2 – paragraph 1 – point 33 – point a

Regulation (EU) 2017/746

Article 51 – paragraph 2

Text proposed by the CommissionAmendment
2. The validity of certificates shall not be limited in time, unless in exceptional cases where the notified body considers it necessary to limit the period of validity based on duly justified grounds. In those cases, the notified body shall indicate the period of validity on the certificate. If the period of validity of the certificate is limited, on application by the manufacturer, the notified body may, following an assessment performed in accordance with Annex VII, Section 4.11, extend the validity of the certificate. Any supplement to a certificate shall remain valid as long as the certificate which it supplements is valid.;2. The validity of certificates shall not be limited in time, except for class C and D or innovative devices for which certificates shall be valid for the period they indicate, which shall not exceed five years. On application by the manufacturer, the validity of the certificate may be extended for further periods, each not exceeding five years, based on a re-assessment in accordance with the applicable conformity assessment procedures. Any supplement to a certificate shall remain valid as long as the certificate which it supplements is valid.
For other class C and class D or innovative devices, the duration of certificates may be limited in exceptional cases where the notified body considers it necessary to limit the period of validity based on duly justified grounds. In those cases, the notified body shall indicate the period of validity on the certificate. If the period of validity of the certificate is limited, on application by the manufacturer, the notified body may, following an assessment performed in accordance with Annex VII, Section 4.11, extend the validity of the certificate. Any supplement to a certificate shall remain valid as long as the certificate which it supplements is valid.’;

Or. en

Amendment 731

Tiemo Wölken

Proposal for a regulation

Article 2 – paragraph 1 – point 33 – point a

Regulation (EU) 2017/746

Article 51 – paragraph 2

Text proposed by the CommissionAmendment
2. The validity of certificates shall not be limited in time, unless in exceptional cases where the notified body considers it necessary to limit the period of validity based on duly justified grounds. In those cases, the notified body shall indicate the period of validity on the certificate. If the period of validity of the certificate is limited, on application by the manufacturer, the notified body may, following an assessment performed in accordance with Annex VII, Section 4.11, extend the validity of the certificate. Any supplement to a certificate shall remain valid as long as the certificate which it supplements is valid.;2. The validity of certificates shall not be limited in time, unless in exceptional cases where the notified body considers it necessary to limit the period of validity based on duly justified grounds. In those cases, the notified body shall indicate the period of validity on the certificate. If the period of validity of the certificate is limited, on application by the manufacturer, the notified body may, following an assessment performed in accordance with Annex VII, Section 4.11, extend the validity of the certificate. Any supplement to a certificate shall remain valid as long as the certificate which it supplements is valid. The validity of the initial certificate for breakthrough and orphan devices shall be limited to a maximum of five years.

Or. en

Amendment 732

Laurent Castillo, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain, Valérie Deloge

Proposal for a regulation

Article 2 – paragraph 1 – point 33 – point b

Regulation (EU) 2017/746

Article 51 – paragraph 2a

Text proposed by the CommissionAmendment
2a. During the validity of the certificate, the notified body shall carry out appropriate surveillance activities, including periodic reviews taking into consideration developments of the state of the art. Those reviews shall be proportionate to the risk class of the device.’;2a. During the validity of the certificate, the notified body shall carry out appropriate surveillance activities, including periodic reviews taking into consideration developments of the state of the art. Those reviews shall be proportionate to the risk class of the device. The periodic reviews shall not constitute a reassessment of elements already assessed during the initial conformity assessment or previous assessments, unless duly justified as a result of significant changes or new risks.’;

Or. fr

Amendment 733

Ruggero Razza, Michele Picaro

Proposal for a regulation

Article 2 – paragraph 1 – point 33 – point b

Regulation (EU) 2017/746

Article 51 – paragraph 2a

Text proposed by the CommissionAmendment
2a. During the validity of the certificate, the notified body shall carry out appropriate surveillance activities, including periodic reviews taking into consideration developments of the state of the art. Those reviews shall be proportionate to the risk class of the device.;2a. During the validity of the certificate, the notified body shall carry out surveillance activities solely to the extent provided for in the relevant annex governing conformity assessment on the basis of which the certificate was issued (Annex IX, Annex X or Annex XI). Such surveillance activities shall be proportionate to the risk class of the device and shall not amount to a reassessment of a scope equivalent to the conformity assessment carried out for the issue of the certificate.

Or. it

Justification

The IVDR certification system already provides for continuous monitoring of certificates, quality management systems and technical documentation, following a quality assurance approach. Additional periodic reviews not defined by the Commission proposal would constitute an overlap in red tape with no real added value. Surveillance should therefore remain proportionate to the device, the risk class and the applicable annexes.

Amendment 734

Stine Bosse, Billy Kelleher

Proposal for a regulation

Article 2 – paragraph 1 – point 33 – point b

Regulation (EU) 2017/746

Article 51 – paragraph 2a

Text proposed by the CommissionAmendment
2a. During the validity of the certificate, the notified body shall carry out appropriate surveillance activities, including periodic reviews taking into consideration developments of the state of the art. Those reviews shall be proportionate to the risk class of the device.;2a. During the validity of the certificate, the notified body shall carry out appropriate surveillance activities, including periodic reviews taking into consideration developments of the state of the art. Those reviews shall be proportionate to the risk class of the device.
Those periodic reviews shall not constitute a re-assessment of elements already assessed during the initial conformity assessment or previous reviews, unless duly justified by significant changes or new risks.;

Or. en

Justification

This amendment ensures proportionality, predictability and efficient use of notified body resources, while maintaining a high level of patient safety.

Clarifying that periodic reviews shall not re-assess elements already evaluated avoids duplicative assessments during the certificate validity period. Without this clarification, the provision risks creating unnecessary administrative burden, longer timelines and reduced system capacity.

At the same time, the amendment fully preserves the existing high level of patient safety by explicitly allowing re-assessment where justified by significant changes or new risks, in line with a lifecycle and risk-based approach. This text reinforces a predictable and proportionate oversight system, supports timely patient access, and safeguards the integrity of the MDR framework in line with the political intention of the Commission's proposal.

Amendment 735

Tiemo Wölken

Proposal for a regulation

Article 2 – paragraph 1 – point 33 – point b

Regulation (EU) 2017/746

Article 51 – paragraph 2a

Text proposed by the CommissionAmendment
2a. During the validity of the certificate, the notified body shall carry out appropriate surveillance activities, including periodic reviews taking into consideration developments of the state of the art. Those reviews shall be proportionate to the risk class of the device.;2a. During the validity of the certificate, the notified body shall carry out appropriate surveillance activities, including periodic reviews, in particular following a certification extension, taking into consideration developments of the state of the art. Those reviews shall be proportionate to the risk class of the device.;

Or. en

Amendment 736

Tiemo Wölken

Proposal for a regulation

Article 2 – paragraph 1 – point 33 – point c

Regulation (EU) 2017/746

Article 51 – paragraph 3

Text proposed by the CommissionAmendment
3. Notified bodies may impose conditions on the certificate’s validity, such as limiting the intended purpose of a device or requiring the manufacturer to undertake specific PMPF studies pursuant to Part B of Annex XIII.;3. Notified bodies may impose conditions on the certificate’s validity, such as limiting the intended purpose of a device or requiring the manufacturer to undertake specific PMPF studies pursuant to Part B of Annex XIII. The validity of the initial certificate for breakthrough and orphan devices shall be limited to a maximum of five years.

Or. en

Amendment 737

Laurent Castillo, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain, Valérie Deloge

Proposal for a regulation

Article 2 – paragraph 1 – point 33 – point d

Regulation (EU) 2017/746

Article 51 – paragraph 4

Text proposed by the CommissionAmendment
Where a notified body finds that the requirements of this Regulation are no longer met by the manufacturer, it shall, taking account of the principle of proportionality, suspend or withdraw the certificate issued or impose any conditions on it unless compliance with such requirements is ensured by appropriate corrective action taken by the manufacturer within an appropriate deadline set by the notified body.’;Where a notified body finds that the requirements of this Regulation are no longer met by the manufacturer, it shall, taking account of the principle of proportionality, suspend or withdraw the certificate issued or impose any conditions on it unless compliance with such requirements is ensured by appropriate corrective action taken by the manufacturer within an appropriate deadline set by the notified body. Before suspending or withdrawing a certificate, the notified body must give the manufacturer the opportunity to submit observations and propose corrective measures, except where immediate action is necessary to remedy an unacceptable risk.’;

Or. fr

Amendment 738

Tiemo Wölken

Proposal for a regulation

Article 2 – paragraph 1 – point 33 – point d

Regulation (EU) 2017/746

Article 51 – paragraph 4

Text proposed by the CommissionAmendment
Where a notified body finds that the requirements of this Regulation are no longer met by the manufacturer, it shall, taking account of the principle of proportionality, suspend or withdraw the certificate issued or impose any conditions on it unless compliance with such requirements is ensured by appropriate corrective action taken by the manufacturer within an appropriate deadline set by the notified body.;Where a notified body finds that the requirements of this Regulation are no longer met by the manufacturer or where the requirements set out in paragraph 3 are not fulfilled, it shall, taking account of the principle of proportionality, suspend or withdraw the certificate issued or impose any conditions on it unless compliance with such requirements is ensured by appropriate corrective action taken by the manufacturer within an appropriate deadline set by the notified body.

Or. en

Amendment 739

Aurelijus Veryga

Proposal for a regulation

Article 2 – paragraph 1 – point 35 – point a

Regulation (EU) 2017/746

Article 54 – paragraph 1

Text proposed by the CommissionAmendment
1. By way of derogation from Article 48, on a duly justified request, any competent authority may authorise for a limited period of time the placing on the market or putting into service within the territory of the Member State concerned of a specific device for which the applicable conformity assessment procedures have not been carried out, provided the use of that device is in the interest of public health, patient safety or patient health.;1. By way of derogation from Article 48, on a duly justified request, any competent authority may authorise for a limited period of time the placing on the market or putting into service within the territory of the Member State concerned of a specific device (including orphan and breakthrough devices) for which the applicable conformity assessment procedures have not been carried out, provided the use of that device is in the interest of public health, patient safety or patient health.;

Or. en

Amendment 740

Laurence Trochu

Proposal for a regulation

Article 2 – paragraph 1 – point 35 – point e

Regulation 2017/746

Article 54 – paragraph 4

Text proposed by the CommissionAmendment
In the event of a public health emergency at Union level recognised in accordance with Article 23 of Regulation (EU) 2022/2371 of the European Parliament and of the Council*****, the Commission may, by means of implementing acts, on its own initiative after consulting the MDCG, authorise the placing on the market or putting into service of a device in accordance with paragraph 3. The authorisation shall cease to apply at the latest when the recognition of the public health emergency is terminated pursuant to Article 23(2) of Regulation (EU) 2022/2371. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3).In the event of a public health emergency at Union level recognised in accordance with Article 23 of Regulation (EU) 2022/2371 of the European Parliament and of the Council*****, the Commission may, by means of implementing acts, on its own initiative after consulting the MDCG, authorise the placing on the market or putting into service of a device in accordance with paragraph 3. The authorisation shall cease to apply at the latest when the recognition of the public health emergency is terminated pursuant to Article 23(2) of Regulation (EU) 2022/2371. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3) and shall be limited to in vitro diagnostic devices used for the medical diagnosis of a serious or life-threatening disease or condition that is directly linked to the public health emergency. Diagnostics authorised in this way cannot be used as a pretext for the implementation of measures restricting fundamental freedoms.

Or. fr

Amendment 741

Tiemo Wölken

Proposal for a regulation

Article 2 – paragraph 1 – point 36

Regulation (EU) 2017/746

Article 54b – paragraph 1 – subparagraph 1

Text proposed by the CommissionAmendment
Member States, on their own initiative or upon a substantiated request by manufacturer or a prospective manufacturer, may establish one or more regulatory sandboxes to which the application of certain requirements of Chapters V or VI or of Annexes I, VIII, IX, X, XI, XIII or XIV would not be appropriate. The Member States shall designate the competent authority that is responsible for the supervision of the regulatory sandbox.Member States, on their own initiative or upon a substantiated request by manufacturer or a prospective manufacturer, may establish one or more regulatory sandboxes to which the application of certain requirements of Chapters V or VI or of Annexes I, VIII, IX, X, XI, XIII or XIV would not be appropriate in light of the innovative scientific or technological characteristics of the device or of an innovative regulatory approach.The Member States shall designate the competent authority that is responsible for the supervision of the regulatory sandbox.

Or. en

Amendment 742

Valentina Palmisano

on behalf of The Left Group

Proposal for a regulation

Article 2 – paragraph 1 – point 36

Regulation (EU) 2017/746

Article 54b – paragraph 1 – subparagraph 1

Text proposed by the CommissionAmendment
Member States, on their own initiative or upon a substantiated request by manufacturer or a prospective manufacturer, may establish one or more regulatory sandboxes to which the application of certain requirements of Chapters V or VI or of Annexes I, VIII, IX, X, XI, XIII or XIV would not be appropriate. The Member States shall designate the competent authority that is responsible for the supervision of the regulatory sandbox.Member States may on their own initiative establish one or more regulatory sandboxes to which the application of certain requirements of Chapters V or VI or of Annexes I, VIII, IX, X, XI, XIII or XIV would not be appropriate. The Member States shall designate the competent authority that is responsible for the supervision of the regulatory sandbox.

Or. en

Amendment 743

Valentina Palmisano

on behalf of The Left Group

Proposal for a regulation

Article 2 – paragraph 1 – point 36

Regulation (EU) 2017/746

Article 54b – paragraph 1 – subparagraph 2

Text proposed by the CommissionAmendment
Member States may also establish regulatory sandboxes jointly with other Member States.deleted

Or. en

Amendment 744

Tiemo Wölken

Proposal for a regulation

Article 2 – paragraph 1 – point 36

Regulation (EU) 2017/746

Article 54b – paragraph 2

Text proposed by the CommissionAmendment
2. The activities within a regulatory sandbox shall take place pursuant to a specific sandbox plan that clearly identify the requirements of this Regulation referred to in paragraph 1, which are temporarily adapted or waived in the regulatory sandbox, a justification that the application of those requirements is not considered to be appropriate and an explanation as to how potential risks related to the adaptation or waiver are to be controlled and mitigated. The plan shall also identify the reasonable duration of the regulatory sandbox necessary to achieve its objectives and the participants in the regulatory sandbox and their respective roles.2. The activities within a regulatory sandbox shall take place pursuant to a specific sandbox plan that clearly identify the requirements of this Regulation referred to in paragraph 1, which are temporarily adapted or, where duly justified,waived in the regulatory sandbox, a justification that the application of those requirements is not considered to be appropriate and an explanation as to how potential risks related to the adaptation or waiver are to be controlled and mitigated. The plan shall also identify the reasonable duration of the regulatory sandbox necessary to achieve its objectives and the participants in the regulatory sandbox and their respective roles. Any temporary adaptation or waiver pursuant to this Article shall not affect the fundamental requirements relating to the safety and performance of devices laid down in this Regulation and shall ensure a high level of protection of public health and patient safety.

Or. en

Amendment 745

Valentina Palmisano

on behalf of The Left Group

Proposal for a regulation

Article 2 – paragraph 1 – point 36

Regulation (EU) 2017/746

Article 54b – paragraph 2

Text proposed by the CommissionAmendment
2. The activities within a regulatory sandbox shall take place pursuant to a specific sandbox plan that clearly identify the requirements of this Regulation referred to in paragraph 1, which are temporarily adapted or waived in the regulatory sandbox, a justification that the application of those requirements is not considered to be appropriate and an explanation as to how potential risks related to the adaptation or waiver are to be controlled and mitigated. The plan shall also identify the reasonable duration of the regulatory sandbox necessary to achieve its objectives and the participants in the regulatory sandbox and their respective roles.2. The activities within a regulatory sandbox shall take place pursuant to a specific sandbox plan that clearly identify the requirements of this Regulation referred to in paragraph 1, which are temporarily adapted or waived in the regulatory sandbox, a justification that the application of those requirements is not considered to be appropriate and an explanation as to how potential risks related to the adaptation or waiver are to be controlled and mitigated. The plan shall also identify the exact duration of the regulatory sandbox necessary to achieve its objectives and the participants in the regulatory sandbox and their respective roles.

Or. en

Amendment 746

Tiemo Wölken

Proposal for a regulation

Article 2 – paragraph 1 – point 36

Regulation (EU) 2017/746

Article 54b – paragraph 3

Text proposed by the CommissionAmendment
3. A regulatory sandbox shall be set up only if the following conditions are met:3. A regulatory sandbox shall be set up only if all of the following conditions are met:

Or. en

Amendment 747

Tiemo Wölken

Proposal for a regulation

Article 2 – paragraph 1 – point 36

Regulation (EU) 2017/746

Article 54b – paragraph 3 – point a

Text proposed by the CommissionAmendment
(a) the device is expected to address unmet medical needs or to provide a significant clinical benefit to patients or to the health system compared with similar existing alternatives or the state of the art;(a) the device is expected to address an unmet medical needs or to provide a significant clinical benefit to patients or to the health system compared with existing alternatives or the state of the art;

Or. en

Amendment 748

Ignazio Roberto Marino

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 2 – paragraph 1 – point 36

Regulation (EU) 2017/746

Article 54b – paragraph 3 – point ba (new)

Text proposed by the CommissionAmendment
(ba) is designed and conducted in such a way that the rights, safety, dignity and well-being of subjects participating in research activities are protected and prevail over all other interests.

Or. en

Amendment 749

Valentina Palmisano

on behalf of The Left Group

Proposal for a regulation

Article 2 – paragraph 1 – point 36

Regulation (EU) 2017/746

Article 54b – paragraph 3 – point ba (new)

Text proposed by the CommissionAmendment
(ba) Assigning the device to a regulatory sandbox would not result in additional risks when compared to the standard regulatory procedure outlined in this Regulation.

Or. en

Amendment 750

Tiemo Wölken

Proposal for a regulation

Article 2 – paragraph 1 – point 36

Regulation (EU) 2017/746

Article 54b – paragraph 5

Text proposed by the CommissionAmendment
5. Any participant in the regulatory sandbox shall, without undue delay, inform the competent authority that is responsible for the supervision of the regulatory sandbox about any harm occurred in relation to the implementation of the regulatory sandbox. The competent authority shall take immediate and adequate corrective measures, including to suspend, revoke or restrict the scope of the regulatory sandbox.5. Any participant in the regulatory sandbox shall, without undue delay, inform the competent authority that is responsible for the supervision of the regulatory sandbox about any incident, serious incident or other event that may adversely affect the safety, health or rights of patients, users or other persons occurred in relation to the implementation of the regulatory sandbox. The competent authority shall take immediate and adequate corrective measures, including to suspend, revoke or restrict the scope of the regulatory sandbox.

Or. en

Amendment 751

Tiemo Wölken

Proposal for a regulation

Article 2 – paragraph 1 – point 36

Regulation (EU) 2017/746

Article 54b – paragraph 6

Text proposed by the CommissionAmendment
6. Manufacturers and prospective manufacturers participating in a regulatory sandbox shall remain liable under applicable Union and national law for any damage inflicted on third parties as a result of their activities taking place in the regulatory sandbox.6. Participation in a regulatory sandbox shall not affect the liability of participants under applicable Union and national liability law. Participants, including manufacturers and prospective manufacturers, shall remain liable for any harm caused to third parties as a result of activities carried out within the regulatory sandbox.

Or. en

Amendment 752

Tiemo Wölken

Proposal for a regulation

Article 2 – paragraph 1 – point 36

Regulation (EU) 2017/746

Article 54b – paragraph 7

Text proposed by the CommissionAmendment
7. The Member State shall inform the Commission and the MDCG about the establishment of a regulatory sandbox and keep them informed about its implementation and outcome.7. The Member State shall inform the Commission and the MDCG about the establishment, implementation and outcome of the regulatory sandbox. The Commission and the MDCG may use the experience gained to support the development of guidance or to assess whether adaptations to the Union regulatory framework are appropriate.

Or. en

Amendment 753

Valentina Palmisano

on behalf of The Left Group

Proposal for a regulation

Article 2 – paragraph 1 – point 36

Regulation (EU) 2017/746

Article 54c – paragraph 1 – subparagraph 1

Text proposed by the CommissionAmendment
The Commission, on its own initiative or upon a substantiated request by a Member State, may establish by means of implementing acts for a limited time and pursuant to a specific plan, Union regulatory sandboxes, which shall inform whether the existing requirements appropriately regulate a specific type of device with particular characteristics or emerging technologies, and there is a risk that the existing requirements:The Commission, on its own initiative or upon a substantiated request by a Member State, may establish by means of implementing acts for a limited time and pursuant to a specific plan, Union regulatory sandboxes, which shall inform whether the existing requirements appropriately regulate a specific type of device with particular characteristics or emerging technologies

Or. en

Amendment 754

Valentina Palmisano

on behalf of The Left Group

Proposal for a regulation

Article 2 – paragraph 1 – point 36

Regulation (EU) 2017/746

Article 54c – paragraph 1 – point a

Text proposed by the CommissionAmendment
(a) would impede or significantly delay the development of such devices and access by healthcare professionals or patients to those devices; ordeleted

Or. en

Amendment 755

Valentina Palmisano

on behalf of The Left Group

Proposal for a regulation

Article 2 – paragraph 1 – point 36

Regulation (EU) 2017/746

Article 54c – paragraph 1 – point b

Text proposed by the CommissionAmendment
(b) would not adequately protect the health and safety of patients, users or other persons or other aspects of public health.deleted

Or. en

Amendment 756

Valentina Palmisano

on behalf of The Left Group

Proposal for a regulation

Article 2 – paragraph 1 – point 36

Regulation (EU) 2017/746

Article 54c – paragraph 1 – subparagraph 2

Text proposed by the CommissionAmendment
Union regulatory sandboxes shall not involve the placing on the market or putting into service of devices which do not comply with this Regulation.Union regulatory sandboxes shall not involve the placing on the market or putting into service of devices which do not comply with this Regulation and they shall comply with the requirements for setting up regulatory sandboxes set out in article 54b, paragraph 3.

Or. en

Amendment 757

Tiemo Wölken

Proposal for a regulation

Article 2 – paragraph 1 – point 36

Regulation (EU) 2017/746

Article 54c – paragraph 1 – subparagraph 2

Text proposed by the CommissionAmendment
Union regulatory sandboxes shall not involve the placing on the market or putting into service of devices which do not comply with this Regulation.Union regulatory sandboxes shall not permit the placing on the market or putting into service of devices which do not comply with this Regulation.

Or. en

Amendment 758

Tiemo Wölken

Proposal for a regulation

Article 2 – paragraph 1 – point 36

Regulation (EU) 2017/746

Article 54c – paragraph 3

Text proposed by the CommissionAmendment
3. The Commission shall inform the MDCG about the establishment of a regulatory sandbox and keep it informed about its outcome.3. The Commission shall keep the MDCG informed about the establishment, implementation and outcome of each Union regulatory sandbox.

Or. en

Amendment 759

Tiemo Wölken

Proposal for a regulation

Article 2 – paragraph 1 – point 36

Regulation (EU) 2017/746

Article 54c – paragraph 4

Text proposed by the CommissionAmendment
4. The Commission may, by means of implementing acts, specify common principles or the detailed arrangements for the establishment, operation and supervision of regulatory sandboxes pursuant to Article 54b or of Union regulatory sandboxes pursuant to this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3).4. The Commission may, by means of implementing acts, specify common principles or the detailed arrangements for the establishment, operation,supervision and evaluation of regulatory sandboxes pursuant to Article 54b or of Union regulatory sandboxes pursuant to this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3).

Or. en

Amendment 760

Tiemo Wölken

Proposal for a regulation

Article 2 – paragraph 1 – point 36

Regulation (EU) 2017/746

Article 54c – paragraph 5

Text proposed by the CommissionAmendment
5. The Commission is empowered to adopt delegated acts in accordance with Article 108 to amend this Article or Article 54b in order to adapt to scientific, technical or regulatory progress and to take into account developments regarding regulatory sandboxes, including in areas other than in vitro diagnostic medical devices.;5. The Commission is empowered to adopt delegated acts in accordance with Article 108 to amend this Article or Article 54b in order to adapt to scientific, technical or regulatory progress and to take into account the experience gained from their implementation regarding regulatory sandboxes.

Or. en

Amendment 761

Tiemo Wölken

Proposal for a regulation

Article 2 – paragraph 1 – point 36

Regulation (EU) 2017/746

Article 54c – paragraph 5a (new)

Text proposed by the CommissionAmendment
5a. The establishment and operation of a Union regulatory sandbox shall not affect the protection of public health or the fundamental requirements relating to the safety and performance of devices laid down in this Regulation.

Or. en

Amendment 762

Tiemo Wölken

Proposal for a regulation

Article 2 – paragraph 1 – point 36 a (new)

Regulation (EU) 2017/746

Article 54ca (new)

Text proposed by the CommissionAmendment
(36a) The following article is inserted
Article 54d
Annual reporting on regulatory sandboxes
The Commission, with input from the Member States and, where relevant, the expert panels referred to in Article 106 of Regulation (EU) 2017/745, as well as the MDCG, shall submit an annual report to the European Parliament and the Council on the implementation of the regulatory sandboxes established in accordance with Articles 54b and 54c. The report shall include, where appropriate, information on the number of regulatory sandboxes established, trends regarding the categories of in vitro medical devices participating in regulatory sandboxes, good practices, difficulties encountered, lessons learnt, reflections on possible future adaptations of the regulatory framework, and recommendations concerning the establishment and operation of regulatory sandboxes and, where relevant, the application of this Regulation and other Union legal acts supervised within the regulatory sandboxes. The Commission shall make those reports, together with lay summaries thereof, publicly available.

Or. en

Amendment 763

Ignazio Roberto Marino

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 2 – paragraph 1 – point 36 a (new)

Regulation (EU) 2017/746

Article 54ca (new)

Text proposed by the CommissionAmendment
(36a) The following article is inserted
Article 54d
Transparency of regulatory sandboxes
Based on the information received from Member States pursuant to Article 54b(7) and on the information shared with the MDCG pursuant to Article 54c(3), the European Commission shall draw up and make publicly available an annual report with a breakdown on the number of sandboxes granted, and detailed information on their implementation and outcomes

Or. en

Amendment 764

Tiemo Wölken

Proposal for a regulation

Article 2 – paragraph 1 – point 36 b (new)

Regulation (EU) 2017/746

Article 54cb (new)

Text proposed by the CommissionAmendment
(36b) The following article is inserted
Article 54e
Sandbox plan
1. Prior to the establishment of a regulatory sandbox, the competent authority of the Member State or, in the case of a Union regulatory sandbox, the Commission shall adopt a sandbox plan. The sandbox plan shall:
(a) identify the participants in the regulatory sandbox and their respective roles;
(b) define the objectives and scope of the regulatory sandbox;
(c) identify the provisions of this Regulation from which temporary derogations are considered necessary for the purposes of the regulatory sandbox, together with the corresponding safeguards;
(d) establish appropriate measures to ensure a high level of protection of public health and patient safety and the rights of participants;
(e) specify the duration of the regulatory sandbox and the conditions for its completion or early termination;
(f) establish the monitoring, reporting and evaluation arrangements applicable to the regulatory sandbox.
2. Before approving a sandbox plan, the competent authority of the Member State or, in the case of a Union regulatory sandbox, the Commission shall consult the MDCG where the regulatory sandbox is likely to have relevance beyond a single Member State or where a coordinated approach would facilitate the consistent application of this Regulation throughout the Union. Where appropriate, notified bodies, laboratories, patient organisations, healthcare professionals and other relevant stakeholders shall also be consulted.
. The Commission shall, after consulting the MDCG, adopt implementing acts laying down a common template and minimum requirements for sandbox plans, including the information to be provided regarding objectives, participants, risk mitigation measures, monitoring, reporting and evaluation. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3).
4. Upon completion of a regulatory sandbox, the competent authority responsible for the national regulatory sandbox or, in the case of a Union regulatory sandbox, the Commission shall submit the sandbox plan and the final evaluation report to the MDCG. The MDCG shall take the results of completed regulatory sandboxes into account when developing guidance and recommendations under this Regulation.

Or. en

Amendment 765

Laurence Trochu

Proposal for a regulation

Article 2 – paragraph 1 – point 38 – point d

Regulation (EU) 2017/746

Article 56 – paragraph 8

Text proposed by the CommissionAmendment
(d) the following paragraph 8 is added:deleted
‘8. The Commission is empowered to adopt delegated acts in accordance with Article 108 to amend Annex XIII in the light of technical and scientific progress and developments at international level having due regard to the protection of the health and safety of patients, users or other persons and other aspects of public health.’;

Or. fr

Amendment 766

Laurent Castillo, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain, Valérie Deloge

Proposal for a regulation

Article 2 – paragraph 1 – point 38 – point d

Regulation (EU) 2017/746

Article 56 – paragraph 8

Text proposed by the CommissionAmendment
8. The Commission is empowered to adopt delegated acts in accordance with Article 108 to amend Annex XIII in the light of technical and scientific progress and developments at international level having due regard to the protection of the health and safety of patients, users or other persons and other aspects of public health.;8. The Commission is empowered to adopt delegated acts in accordance with Article 108 to amend Annex XIII in the light of technical and scientific progress and developments at international level having due regard to the protection of the health and safety of patients, users or other persons and other aspects of public health. Before adopting delegated acts, the Commission shall consult the MDCG, notified bodies, manufacturers, healthcare professionals and patient organisations.;

Or. fr

Amendment 767

Aurelijus Veryga

Proposal for a regulation

Article 2 – paragraph 1 – point 39

Regulation (EU) 2017/746

Article 56a

Text proposed by the CommissionAmendment
For class C and class D devices, a manufacturer may, prior to its performance study or clinical performance evaluation, consult an expert panel as referred to in Article 106 of Regulation (EU) 2017/745, with the aim of reviewing the manufacturer’s intended strategy for demonstrating clinical performance or proposals for any clinical performance study. The manufacturer and the notified body involved in any future conformity assessment procedure shall, in the performance evaluation report and the performance evaluation assessment report, give due consideration to the advice of the expert panel, and where they do not follow that advice, they shall provide duly justified reasons.;For class C and class D devices, an IVD manufacturer and the sponsor of the clinical trial(s) may, prior to its performance study or clinical performance evaluation, consult an expert panel as referred to in Article 106 of Regulation (EU) 2017/745, with the aim of reviewing the combined study’s intended strategy for demonstrating clinical performance or proposals for any clinical performance study. Notified Bodies should be able to participate. The IVD manufacturer, sponsor of the clinical trial(s), and the notified body involved in any future conformity assessment procedure shall, in the performance evaluation report and the performance evaluation assessment report, give due consideration to the advice of the expert panel, and where they do not follow that advice, they shall provide duly justified reasons. They may ask expert panels to clarify the opinion it has provided.

Or. en

Amendment 768

Tiemo Wölken

Proposal for a regulation

Article 2 – paragraph 1 – point 40 – point b

Regulation (EU) 2017/746

Article 58 – paragraph 1 – point c

Text proposed by the CommissionAmendment
(c) where the conduct of the study involves additional invasive procedures, including high-risk procedures for collection of specimens, or other risks for the subjects of the studies,;(c) where the conduct of the study involves additional invasive procedures, including high-risk procedures for collection of specimens, or other risks for the subjects of the studies. Routine venous or capillary blood collection shall not, in itself, constitute an additional invasive procedure for the purposes of this Article, unless the volume or frequency of blood collection presents a significant risk to the subject.

Or. en

Amendment 769

Adam Jarubas

Proposal for a regulation

Article 2 – paragraph 1 – point 40 – point b

Regulation (EU) 2017/746

Article 58 – paragraph 1 – point c

Text proposed by the CommissionAmendment
(c) where the conduct of the study involves additional invasive procedures, including high-risk procedures for collection of specimens, or other risks for the subjects of the studies,;(c) where the conduct of the study involves additional invasive procedures that might pose a major clinical risk to subjects, or other risks for the subjects of the studies, shall, in addition to meeting the requirements set out in Article 57 and Annex XIII, be designed, authorised, conducted, recorded and reported in accordance with this Article and Articles 59 to 77 and Annex XIV.

Or. en

Justification

The term “invasive procedures” in point c could encompass low-risk activities, such as standard blood sampling and finger-prick tests, which would nevertheless fall within the general authorisation requirement for “specimen collection”. This appears inconsistent with the Commission’s summary, which indicated that the scope would be narrowed. It is also difficult to reconcile with recital 50, which refers to a simplified approach for low-risk procedures, including routine blood draws carried out on non-vulnerable individuals.

Amendment 770

Laurence Trochu

Proposal for a regulation

Article 2 – paragraph 1 – point 40 – point b

Regulation (EU) 2017/746

Article 58 – paragraph 1 – point c

Text proposed by the CommissionAmendment
(c) where the conduct of the study involves additional invasive procedures, including high-risk procedures for collection of specimens, or other risks for the subjects of the studies,’;(c) point (c) is replaced by the following:
where the conduct of the study involves additional invasive procedures, excluding routine blood draws from non-vulnerable individuals, but including high-risk procedures for collection of specimens, or other risks for the subjects of the studies,’;

Or. fr

Justification

This clarification is necessary and in line with recital 50 of the legislative proposal.

Amendment 771

Aurelijus Veryga

Proposal for a regulation

Article 2 – paragraph 1 – point 40 – point b

Regulation (EU) 2017/746

Article 58 – paragraph 1 – point c

Text proposed by the CommissionAmendment
(c) where the conduct of the study involves additional invasive procedures, including high-risk procedures for collection of specimens, or other risks for the subjects of the studies,;(c) Where the conduct of the study involves additional invasive procedures, excluding routine blood draws from non-vulnerable individuals, and including high-risk procedures for collection of specimens, or other risk for the subjects of the studies. ;

Or. en

Amendment 772

Kristoffer Storm

Proposal for a regulation

Article 2 – paragraph 1 – point 40 – point b

Regulation (EU) 2017/746

Article 58 – paragraph 1 – point c

Text proposed by the CommissionAmendment
(c) where the conduct of the study involves additional invasive procedures, including high-risk procedures for collection of specimens, or other risks for the subjects of the studies,;(c) where the conduct of the study involves additional invasive procedures that might pose a major clinical risk to subjects, or other risks for the subjects of the studies

Or. en

Amendment 773

Tiemo Wölken

Proposal for a regulation

Article 2 – paragraph 1 – point 53 – point a – point ii

Regulation (EU) 2017/746

Article 81 –paragraph 1 – subparagraph 2

Text proposed by the CommissionAmendment
Manufacturers of class C and class D devices shall update the PSUR in the first year after the certificate is issued and every two years thereafter or when there is a significant change in the benefit-risk determination or in the acceptability of erroneous results. That PSUR shall be part of the technical documentation specified in Annex III.;Manufacturers of class C and class D devices shall update the PSUR in the first year after the certificate is issued and every two years thereafter or when there is a significant change in the benefit-risk determination or in the acceptability of erroneous results. Where the notified body has limited the validity of a certificate in accordance with Article 51(3), the PSUR shall be updated annually for the duration of that period of limited validity in order to support the assessment of compliance with the conditions attached to the certificate .That PSUR shall be part of the technical documentation specified in Annex III.

Or. en

Amendment 774

Laurent Castillo, Marie-Luce Brasier-Clain, Valérie Deloge

Proposal for a regulation

Article 2 – paragraph 1 – point 54 – point -a (new)

Regulation (EU) 2017/746

Article 82 – first paragraph

Text proposed by the CommissionAmendment
– in the first subparagraph, the introductory wording is replaced by the following:
1. Manufacturers of devices made available on the Union market, other than devices for performance study, shall report to the authority responsible for the notified body that issued the certificate, in accordance with Articles 87(5) and (7), the following:

Or. fr

Amendment 775

Valentina Palmisano

on behalf of The Left Group

Proposal for a regulation

Article 2 – paragraph 1 – point 54 – point b

Regulation (EU) 2017/746

Article 82 – paragraph 3

Text proposed by the CommissionAmendment
3. Manufacturers shall report any serious incident as referred to in paragraph 1, first subparagraph, point (a), immediately after they have established that there is a causal relationship between that incident and their device or that such causal relationship is reasonably possible, and not later than 30 days after they become aware of the incident.;3. Manufacturers shall report any serious incident as referred to in paragraph 1, first subparagraph, point (a), immediately after they have established that there is a causal relationship between that incident and their device or that such causal relationship is reasonably possible, and not later than 15 days after they become aware of the incident.;

Or. en

Justification

To reflect current standards.

Amendment 776

Laurence Trochu

Proposal for a regulation

Article 2 – paragraph 1 – point 54 – point b

Regulation (EU) 2017/746

Article 82 – paragraph 3

Text proposed by the CommissionAmendment
3. Manufacturers shall report any serious incident as referred to in paragraph 1, first subparagraph, point (a), immediately after they have established that there is a causal relationship between that incident and their device or that such causal relationship is reasonably possible, and not later than 30 days after they become aware of the incident.;3. Manufacturers shall report any serious incident as referred to in paragraph 1, first subparagraph, point (a), immediately after they have established that there is a causal relationship between that incident and their device or that such causal relationship is reasonably possible, and not later than 15 days after they become aware of the incident.;

Or. fr

Amendment 777

Adam Jarubas

Proposal for a regulation

Article 2 – paragraph 1 – point 55

Regulation (EU) 2017/746

Article 82a

Text proposed by the CommissionAmendment
(55) The following Article 82a is inserted:deleted
‘Article 82a
Reporting of actively exploited vulnerabilities and severe incidents related to devices
1. Without prejudice to the reporting obligations regarding serious incidents and field safety corrective actions set out in Article 82, the manufacturer of a device shall report to the computer security incident response teams (‘CSIRTs’), designated as coordinators of the Member States where a device has been made available, and to the European Union Agency for Cybersecurity (ENISA), either of the following:
(a) any actively exploited vulnerability as defined in Article 3, point (42), of Regulation (EU) 2024/2847 of the European Parliament and of the Council******** contained in the device;
(b) any severe incident as referred in Article 14(5) of Regulation (EU) 2024/2847 having an impact on the security of the device.
2. The manufacturer shall submit the report referred to in paragraph 1 through the electronic system referred to in Article 87 not later than 30 days after it becomes aware of the actively exploited vulnerability or the severe incident.
3. The report referred to in paragraph 1, as well as any report submitted by a manufacturer in accordance with Article 82 that also qualifies as actively exploited vulnerability or severe incident, shall be made available simultaneously to the CSIRTs designated as coordinators of the Member States in which the device has been made available and to ENISA
4.
For the purposes of this Article, the CSIRTs designated as coordinators and ENISA shall have access to Eudamed.
******** Regulation (EU) 2024/2847 of the European Parliament and of the Council of 23 October 2024 on horizontal cybersecurity requirements for products with digital elements and amending Regulations (EU) No 168/2013 and (EU) 2019/1020 and Directive (EU) 2020/1828 (Cyber Resilience Act) (OJ L, 2024/2847, 20.11.2024, ELI: http://data.europa.eu/eli/reg/2024/2847/oj).;’

Or. en

Amendment 778

Adam Jarubas

Proposal for a regulation

Article 2 – paragraph 1 – point 55 a (new)

Regulation (EU) 2017/746

Article 82a a (new)

Text proposed by the CommissionAmendment
(55a) the following Article 82a is inserted:
‘
Article 82a
Reporting of cybersecurity incidents and coordinated vulnerability disclosure
1. The manufacturer of a device shall consider:
(a) any actively exploited vulnerability as defined in Article 3, point (42), of Regulation (EU) 2024/2847 of the European Parliament and of the Council, contained in the device;
(b) any severe incident as referred in Article 14(5) of Regulation (EU) 2024/2847 having an impact on the security of the device as serious incident which shall be proceeded according to Article 87 and 89.
2. The manufacturer shall submit initial report of serious incident referred to in paragraph 1 through the electronic system referred to in Article 92 without undue delay and in any event within 24 hours of the manufacturer becoming aware of it, to the competent authority and to the computer security incident response teams (‘CSIRTs’), designated as coordinators of the Member States where a device has been made available and to ENISA.
3. Competent authorities shall cooperate with computer security incident response teams (‘CSIRTs’), designated as coordinators of the Member States where a device has been made available, when resolving serious incidents referred to in paragraph 1. The cooperation shall include exchange of all information in reference to reported exploited vulnerability or severe incident between competent authority, CSIRT and ENISA.
4. For the purposes of this Article, the CSIRTs designated as coordinators and ENISA shall have access to Eudamed.
5. CSIRTs may act as coordinator for the purpose of coordinated vulnerability disclosure for devices as set out in Article 12 of Directive (EU) 2022/2555 and shall cooperate with competent authority.
’

Or. en

Justification

Both kinds of incidents referred to in article 87a paragraph 1 in the CRA are considered triggering immediate notification and having serious impact. We should keep the analogous perspective. The early warning in article 87a paragraph 2 aligns the provisions with CRA. Furthermore, if we try to match reporting exploited vulnerabilities and severe incidents as defined in CRA we should look into timelines which refer to serious public health threat, because it is a scale relevant to a risk connected to them. The vulnerability or severe incident not always is connected with risk of death or serious illness. That’s why the provisions of MDR/IVDR have to specify that. Risk caused by vulnerability in the software influence the same moment to every user of the device and it may be really significant amount of people. So if we adjust timelines to MDR/IVDR timelines, the deadline for serious public health threat would be the most relevant. Furthermore, it has to be clearly specified that CSIRT and CA are able to cooperate without limitation in reference to exchange of information. Such data are sensitive and have to be protected, but in reference to MD this exchange is needed because of safety of patients and users. It is necessary to cover a gap in NIS2 directive, which relates CVD (coordinated vulnerability disclosure) to ICT products.

Amendment 779

Michele Picaro, Ruggero Razza

Proposal for a regulation

Article 2 – paragraph 1 – point 71 a (new)

Regulation (EU) 2017/746

Article 103

Text proposed by the CommissionAmendment
(71a) Article 103 is deleted;

Or. en

Amendment 780

Michele Picaro, Ruggero Razza

Proposal for a regulation

Article 2 – paragraph 1 – point 72

Regulation (EU) 2017/746

Article 103

Text proposed by the CommissionAmendment
(72) Article 103 is amended as follows:deleted
‘(a) in paragraph 1, the reference to ‘Directive 95/46/EC’ is replaced by ‘Regulation (EU) 2016/679’;
(b)
in paragraph 2, the reference to ‘Regulation (EC) No 45/2001’ is replaced by ‘Regulation (EU) 2018/1725 of the European Parliament and of the Council*********.
********* Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39, ELI: http://data.europa.eu/eli/reg/2018/1725/oj).’

Or. en

Amendment 781

Tiemo Wölken

Proposal for a regulation

Article 2 – paragraph 1 – point 77

Regulation (EU) 2017/746

Article 109

Text proposed by the CommissionAmendment
(77) Article 109 is deleted;deleted

Or. en

Amendment 782

Aurelijus Veryga

Proposal for a regulation

Article 2 – paragraph 1 – point 78

Regulation (EU) 2017/746

Article 110 – paragraph 12 – subparagraph 1

Text proposed by the CommissionAmendment
By way of derogation from Article 5 and from paragraphs 3 to 3e of this Article, a device as referred to in paragraph 3a or paragraph 3b of this Article that meets the criteria for an orphan device set out in Article 48a(3) may be placed on the market or put into service beyond the dates referred to in paragraphs 3a and 3b if the following conditions are met:By way of derogation from Article 5 and from paragraphs 3 to 3e of this Article, a device as referred to in paragraph 3a or paragraph 3b of this Article that meets the criteria for an orphan device or niche device set out in Article 48a(3) or a niche device may be placed on the market or put into service beyond the dates referred to in paragraphs 3a and 3b if the following conditions are met::
(1)

Or. en

Amendment 783

Viktória Ferenc, Ondřej Knotek, Laurent Castillo, Valérie Deloge

Proposal for a regulation

Article 2 – paragraph 1 – point 78

Regulation (EU) 2017/746

Article 110 – paragraph 12 – subparagraph 1

Text proposed by the CommissionAmendment
By way of derogation from Article 5 and from paragraphs 3 to 3e of this Article, a device as referred to in paragraph 3a or paragraph 3b of this Article that meets the criteria for an orphan device set out in Article 48a(3) may be placed on the market or put into service beyond the dates referred to in paragraphs 3a and 3b if the following conditions are met:By way of derogation from Article 5 and from paragraphs 3 to 3e of this Article, a device as referred to in paragraph 3a or paragraph 3b of this Article that meets the criteria for an orphan device or niche device set out in Article 48a(3) may be placed on the market or put into service beyond the dates referred to in paragraphs 3a and 3b if the following conditions are met:

Or. en

Justification

By allowing continued market access beyond the transition deadlines for devices that fulfil unmet medical needs and are actively progressing towards compliance, the provision helps prevent shortages, supports continuity of care, and ensures that patients and healthcare professionals retain access to essential technologies for which suitable alternatives may not exist.

Amendment 784

Tiemo Wölken

Proposal for a regulation

Article 2 – paragraph 1 – point 79 – introductory part

Regulation (EU) 2017/746

Article 111

Text proposed by the CommissionAmendment
(79) Article 111 is amended as follows:(79) Article 111 is amended as follows:
'Five years after the date of entry into force of the Amendment, and every 10 years after, the Commission shall assess the application of this Regulation and produce an evaluation report on the progress towards achievement of the objectives contained herein, while maintaining the high level of protection of health and safety of patients, users and other persons provided for by this Regulation. including an assessment of the resources required to implement this Regulation. The evaluation shall also include a review on the functioning of Article 4.
2. The evaluation shall, in particular, assess:
(a) the effectiveness of the measures introduced to simplify the regulatory framework and reduce the administrative burden on manufacturers, notified bodies, laboratories and competent authorities, including their impact on regulatory efficiency, legal certainty and the timely availability of in vitro diagnostic medical devices on the Union market;
(b) the functioning and effectiveness of the regulatory sandboxes established under this Regulation, including their contribution to innovation, regulatory learning, regulatory convergence and the development of guidance, common specifications, implementing acts or legislative proposals;
(c) the effectiveness of the framework for well-established technologies, including its impact on regulatory efficiency, innovation, patient access, post-market performance and safety, and whether the eligibility criteria remain appropriate in light of scientific and technological developments; (f) the application of the accelerated conformity assessment pathway for orphan and breakthrough in vitro diagnostic medical devices, including its impact on timely patient access, innovation, generation of performance evidence, post-market performance follow-up and the availability of such devices throughout the Union;
(d) the impact of the measures strengthening stakeholder involvement, including the participation of patients, healthcare professionals, laboratories and their representative organisations in the work of the MDCG, vigilance activities and Eudamed, and their contribution to the transparency, quality and legitimacy of regulatory decision-making;
(e) the functioning of Eudamed, including its contribution to transparency, traceability, coordination between Member States, access to information for patients, healthcare professionals, laboratories and the public, and the effectiveness of its publicly accessible modules;
(f) the effectiveness of the measures introduced to improve the availability of in vitro diagnostic medical devices and to prevent or mitigate shortages, including their impact on continuity of supply, diagnostic preparedness and the availability of critical diagnostics within the Union;
(g) the impact of the measures introduced to facilitate structured scientific, technical and regulatory dialogue between manufacturers and notified bodies on the efficiency, predictability and quality of conformity assessment procedures, while preserving the independence, objectivity and impartiality of notified bodies;
(h) the impact of the revised framework on the availability of companion diagnostics and other high-risk in vitro diagnostic medical devices supporting personalised medicine and public health;
(i) whether the simplification measures introduced by this Regulation have maintained an appropriate balance between facilitating innovation and ensuring the generation of sufficient scientific validity, analytical performance and clinical performance evidence throughout the lifecycle of in vitro diagnostic medical devices, including through post-market performance follow-up;
(j) whether the simplification measures introduced by this Regulation have had any unintended consequences affecting the safety or performance of in vitro diagnostic medical devices, the effectiveness of market surveillance, vigilance or post-market performance follow-up activities, or the overall level of protection of public health.
3. The evaluation shall be based, inter alia, on information provided by Member States, competent authorities, the Medical Device Coordination Group, expert panels, notified bodies, manufacturers, healthcare professionals, laboratories, patient organisations and other relevant stakeholders, as well as data available through Eudamed.
4. The Commission shall make the findings of the evaluation publicly available. Where appropriate, the Commission shall accompany the report with legislative proposals to amend this Regulation.

Or. en

Amendment 785

Ignazio Roberto Marino

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 4

Regulation (EU) 2024/1689

Annex I

Text proposed by the CommissionAmendment
Article 4deleted
Amendments to Regulation (EU) 2024/1689
Annex I to Regulation (EU) 2024/1689 is amended as follows:
(1) in Section A, points 11 and 12 are deleted;
(2) in Section B, the following points are added:
‘21. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p.1);
22. Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176)..

Or. en

Justification

No change should be made to applicability of the AI act.

Amendment 786

Tiemo Wölken

Proposal for a regulation

Article 4

Regulation (EU) 2024/1689

Annex I

Text proposed by the CommissionAmendment
Article 4deleted
Amendments to Regulation (EU) 2024/1689
Annex I to Regulation (EU) 2024/1689 is amended as follows:
(1) in Section A, points 11 and 12 are deleted;
(2) in Section B, the following points are added:
‘21. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p.1);
22. Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176)..

Or. en

Amendment 787

Tomislav Sokol

Proposal for a regulation

Article 4

Regulation (EU) 2024/1689

Annex I

Text proposed by the CommissionAmendment
Article 4deleted
Amendments to Regulation (EU) 2024/1689
Annex I to Regulation (EU) 2024/1689 is amended as follows:
(1) in Section A, points 11 and 12 are deleted;
(2) in Section B, the following points are added:
‘21. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p.1);
22. Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176)..

Or. en

Amendment 788

Kateřina Konečná

Proposal for a regulation

Article 4

Regulation (EU) 2024/1689

Annex I

Text proposed by the CommissionAmendment
Article 4deleted
Amendments to Regulation (EU) 2024/1689
Annex I to Regulation (EU) 2024/1689 is amended as follows:
(1) in Section A, points 11 and 12 are deleted;
(2) in Section B, the following points are added:
‘21. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p.1);
22. Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176)..

Or. en

Amendment 789

Letizia Moratti, Dolors Montserrat, Elena Nevado del Campo

Proposal for a regulation

Annex I – paragraph 1 – point 1 – point a a (new)

Regulation (EU) 2017/745

Annex I – Section 12.2

Present textAmendment
12.2 Devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body, and that are absorbed by or locally dispersed in the human body shall comply, where applicable and in a manner limited to the aspects not covered by this Regulation, with the relevant requirements laid down in Annex I to Directive 2001/83/EC for the evaluation of absorption, distribution, metabolism, excretion, local tolerance, toxicity, interaction with other devices, medicinal products or other substances and potential for adverse reactions, as required by the applicable conformity assessment procedure under this Regulation."12.2 Devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body, and that are absorbed by or locally dispersed in the human body shall be assessed for the matter referring to absorption, distribution, metabolism, excretion, local tolerance, toxicity, interaction with other devices, medicinal products or other substances and potential for adverse reactions, as required by the applicable conformity assessment procedure under this Regulation and having regard to the state of the art and to the characteristics of the substance(s) concerned."

Or. en

(2017/745)

Justification

Removing the reference to Directive 2001/83/EC (the legislation governing medicinal products) eliminates an unnecessary source of regulatory uncertainty. Medical devices and medicinal products operate through different mechanisms and are subject to separate regulatory frameworks. It is therefore neither appropriate nor scientifically justified to require medical device manufacturers to address the aspects set out in essential requirement 12.2 using an approach developed for medicinal products, as this may unnecessarily hinder innovation and delay access to products that meet emerging healthcare needs.

To maintain a high level of patient safety, the amendment preserves the manufacturer's obligation to rigorously assess those aspects through an approach specifically designed for medical devices, ensuring equivalent safety outcomes. This is consistent with the initiative’s main objectives of simplification, legal certainty, and regulatory coherence for medical devices within the EU.

Amendment 790

Adam Jarubas

Proposal for a regulation

Annex I – paragraph 1 – point 1 – point c a (new)

Regulation (EU) 2017/745

Annex I – Sections 17.4a (new) and 17.4b (new)

Text proposed by the CommissionAmendment
(ca) the following sections 17.5 and 17.6 are added:
‘
17.5 Connected devices shall comply with the essential cybersecurity requirements set out in Annex I, Part I, point 2, letter (a) to (l) of Regulation (EU) 2024/2847 of the European Parliament and of the Council, taking into consideration benefit-risk ratio of the device and intended user.
17.6 Manufacturer of connected devices shall fulfil requirements specified in Annex I, Part II of regulation mentioned in paragraph 17.5.1.
’

Or. en

Amendment 791

Tiemo Wölken

Proposal for a regulation

Annex I – paragraph 1 – point 1 – point d – point i

Regulation (EU) 2017/745

Annex I – Section 23.1 – subparagraph 1

Text proposed by the CommissionAmendment
(i) in the first subparagraph, the second sentence is replaced by the following:deleted
‘Such information may appear on the device itself, on the packaging or in the instructions for use, taking into account the following:;’

Or. en

Amendment 792

Tiemo Wölken

Proposal for a regulation

Annex I – paragraph 1 – point 1 – point d – point iv

Regulation (EU) 2017/745

Annex I – Section 23.1 – point i

Text proposed by the CommissionAmendment
(i) For a device that is exclusively in use with a medicinal product in accordance with Article 19 of [Proposal for a Directive on the Union code relating to medicinal products for human use, and repealing Directive 2011/83/EC and Directive 2009/35/EC] and packaged together with a medicinal product, the instructions for use may be included, where needed, as part of the co-packaging of the medicinal product with the device. Moreover, the information on the label of the device may be limited to the particulars referred to in Section 23.2, points (a) and (c), where, following agreement of the competent authority responsible for the authorisation of the medicinal product, the following conditions are met:(i) For a device that is exclusively in use with a medicinal product in accordance with Article 19 of [Proposal for a Directive on the Union code relating to medicinal products for human use, and repealing Directive 2011/83/EC and Directive 2009/35/EC] and packaged together with a medicinal product, the instructions for use shall be included, where needed, as part of the co-packaging of the medicinal product with the device. Moreover, the information on the label of the device may be limited to the particulars referred to in Section 23.2, points (a) and (c), where, following agreement of the competent authority responsible for the authorisation of the medicinal product, the following conditions are met:

Or. en

Amendment 793

Tiemo Wölken

Proposal for a regulation

Annex I – paragraph 1 – point 1 – point d – point iv

Regulation (EU) 2017/745

Annex I– Section 23.1 – point i – indent 2a (new)

Text proposed by the CommissionAmendment
(ia) - electronic or digital means used to provide access to the instructions for use shall comply with Regulation (EU) 2016/679 and shall not permit the identification, profiling or tracking of patients beyond what is necessary for the provision of that information.

Or. en

Amendment 794

Tiemo Wölken

Proposal for a regulation

Annex I – paragraph 1 – point 1 – point e – point ii

Regulation (EU) 2017/745

Annex I – Section 23.2 – point o

Text proposed by the CommissionAmendment
(ii) point (o) is deleted;deleted

Or. en

Amendment 795

Ruggero Razza, Michele Picaro

Proposal for a regulation

Annex I – paragraph 1 – point 1 a (new)

Regulation (EU) 2017/745

Annex I – Section 12.2

Present textAmendment
12.2‘12.2.
Devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body, and that are absorbed by or locally dispersed in the human body shall comply, where applicable and in a manner limited to the aspects not covered by this Regulation, with the relevant requirements laid down in Annex I to Directive 2001/83/EC for the evaluation of absorption, distribution, metabolism, excretion, local tolerance, toxicity, interaction with other devices, medicinal products or other substances and potential for adverse reactions, as required by the applicable conformity assessment procedure under this Regulation.Devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body, and that are absorbed by or locally dispersed in the human body shall, where applicable, also be assessed for aspects relating to the absorption, distribution, metabolism, excretion, local tolerance, toxicity, interaction with other devices, medicinal products or other substances and potential for adverse reactions, as required by the applicable conformity assessment procedure under this Regulation and taking into account the state of the art and the characteristics of the substances.

Or. it

(2017/745 (MDR))

Justification

This amendment removes the reference to Directive 2001/83/EC on medicinal products, which creates legal uncertainty and unnecessary burdens, as medical devices and medicinal products are governed by separate frameworks. Security remains guaranteed: manufacturers will continue to assess the relevant aspects of requirement 12.2 with device-specific methods. The amendment will boost the clarity, regulatory coherence, innovation and the timely availability of new health solutions.

Amendment 796

Tiemo Wölken

Proposal for a regulation

Annex I – paragraph 1 – point 2 a (new)

Regulation (EU) 2017/745

Annex II – Section 1.1 – point la (new)

Text proposed by the CommissionAmendment
(2a) the following point (m) is introduced:
'an indication of whether the device is intended for single use or is suitable for reprocessing for reuse, together with the grounds for that designation, including why safe reprocessing cannot be ensured.'

Or. en

Amendment 797

Tiemo Wölken

Proposal for a regulation

Annex I – paragraph 1 – point 4 – point a

Regulation (EU) 2017/745

Annex VI – Part B – point 34a (new)

Text proposed by the CommissionAmendment
(35) identification number of the notified body responsible for the conformity assessment procedures set out in Article 52.

Or. en

Amendment 798

Laurent Castillo, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain, Valérie Deloge

Proposal for a regulation

Annex I – paragraph 1 – point 5 – point c

Regulation (EU) 2017/745

Annex VII – Section 1.2.9.

Text proposed by the CommissionAmendment
The notified body shall have documented procedures in place to offer and carry out dialogues with the manufacturer before and after an application for conformity assessment is lodged.’;The notified body shall have documented procedures in place to offer and carry out dialogues with the manufacturer before and after an application for conformity assessment is lodged. That dialogue may take the form of structured and interactive exchanges, including consultations both before the application is lodged and throughout the conformity assessment procedure.

Or. fr

Amendment 799

Aurelijus Veryga

Proposal for a regulation

Annex I – paragraph 1 – point 5 – point c

Regulation (EU) 2017/746

Annex VII – Section 1.2.9

Text proposed by the CommissionAmendment
The notified body shall have documented procedures in place to offer and carry out dialogues with the manufacturer before and after an application for conformity assessment is lodged.;The notified body shall have documented procedures in place to offer and carry out dialogues with the manufacturer before and after an application for conformity assessment is lodged. These dialogues may include structured and interactive exchanges, including pre-submission consultations, and consultations throughout the conformity assessment procedure.;

Or. en

Amendment 800

Tiemo Wölken

Proposal for a regulation

Annex I – paragraph 1 – point 5 – point c

Regulation (EU) 2017/745

Annex VII – Section 1.2.9

Text proposed by the CommissionAmendment
The notified body shall have documented procedures in place to offer and carry out dialogues with the manufacturer before and after an application for conformity assessment is lodged.;The notified body shall have documented procedures in place to offer and carry out dialogues, including early dialogue, with the manufacturer before and after an application for conformity assessment is lodged.

Or. en

Amendment 801

Laurent Castillo, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain, Valérie Deloge

Proposal for a regulation

Annex I – paragraph 1 – point 5 – point z

Regulation (EU) 2017/745

Annex VII – Section 4.11.

Text proposed by the CommissionAmendment
The notified body shall have documented procedures in place relating to periodic reviews of approved quality management systems or EU technical documentation assessment certificates or EU type-examination certificates.The notified body shall have documented procedures in place relating to periodic reviews of approved quality management systems or EU technical documentation assessment certificates or EU type-examination certificates. Notified bodies, taking into account the coordination activities referred to in Article 49, shall ensure uniform application of these provisions.

Or. fr

Amendment 802

Tiemo Wölken

Proposal for a regulation

Annex I – paragraph 1 – point 5 – point z

Regulation (EU) 2017/745

Annex VII – Section 4.11

Text proposed by the CommissionAmendment
The notified body shall have documented procedures in place relating to the extension of the period of validity of a certificate in cases where it has exceptionally limited the period of validity. Those procedures shall require the manufacturer to submit prior to the expiry of the certificate the data or documentation specified by the notified body to enable it to decide about the extension of the period of validity of the certificate.;The notified body shall have documented procedures in place relating to the extension of the period of validity of a certificate in cases where it has limited the period of validity. Those procedures shall require the manufacturer to submit prior to the expiry of the certificate the data or documentation specified by the notified body to enable it to decide about the extension of the period of validity of the certificate.;

Or. en

Amendment 803

Tiemo Wölken

Proposal for a regulation

Annex I – paragraph 1 – point 5 a (new)

Regulation (EU) 2017/745

Annex VII – Section 1.2.9

Present textAmendment
(5a) Annex VII - 1.2.9 is replaced by the following:
1.2.9. The requirements laid down in this Section in no way preclude exchanges of technical information and regulatory guidance between a notified body and a manufacturer applying for conformity assessment."1.2.9. The requirements laid down in this Section in no way preclude exchanges of technical information, regulatory guidance and early dialogue between a notified body and a manufacturer applying for conformity assessment. The notified body shall have documented procedures in place to offer and carry out dialogues, including early dialogue, with the manufacturer before and after an application for conformity assessment is lodged."

Or. en

(Regulation (EU) 2017/745)

Amendment 804

Adam Jarubas

Proposal for a regulation

Annex I – paragraph 1 – point 6 – point b

Regulation (EU) 2017/745

Annex VIII – Section 4.2 – paragraph 1 – indent 2

Text proposed by the CommissionAmendment
- if they are intended for use for channeling or storing blood or other body liquids or for storing organs, parts of organs or body cells and tissues, except for blood bags; by derogation from any other classification rule, blood bags are classified as class IIb.;- if they are intended for use for channeling or storing blood or other body liquids or for storing organs, parts of organs or body cells and tissues, except for blood bags; blood bags are classified as class IIb.;

Or. en

Justification

This amendment ensures legal clarity, supporting continuity of supply and regulatory stability by preserving the recently harmonised classification framework for blood bags under the MDR. It removes the proposed derogation clause, which would introduce ambiguity by overruling Rule 14 and creating uncertainty as to the applicable classification for blood bags containing substances meeting the definition of a medicinal product under Directive 2001/83/EC. Maintaining the current framework avoids reinstating discrepancies in the regulatory treatment of identical substances depending on whether they are incorporated into a blood bag or supplied separately, in line with current EMA and MDCG positions. It also ensures continuity of supply by avoiding the operational burden that any reclassification would entail, including updates to labelling, technical documentation and national registrations.

Amendment 805

András Tivadar Kulja

Proposal for a regulation

Annex I – paragraph 1 – point 6 – point b

Regulation (EU) 2017/745

Annex VIII – Section 4.2 – paragraph 1 – indent 2

Text proposed by the CommissionAmendment
- if they are intended for use for channeling or storing blood or other body liquids or for storing organs, parts of organs or body cells and tissues, except for blood bags; by derogation from any other classification rule, blood bags are classified as class IIb.;- if they are intended for use for channeling or storing blood or other body liquids or for storing organs, parts of organs or body cells and tissues, except for blood bags; blood bags are classified as class IIb.;

Or. en

Amendment 806

Ondřej Knotek, Laurent Castillo, Marie-Luce Brasier-Clain, Viktória Ferenc, Valérie Deloge

Proposal for a regulation

Annex I – paragraph 1 – point 6 – point g

Regulation (EU) 2017/745

Annex VIII – Section 6.3

Text proposed by the CommissionAmendment
Rule 11 shall be applied in a manner that clearly distinguishes the criteria determining whether software constitutes a medical device from the criteria for its classification under this Annex. The classification of software shall be based on its intended purpose and the applicable classification criteria set out in this Rule.

Or. en

Amendment 807

Sirpa Pietikäinen

Proposal for a regulation

Annex I – paragraph 1 – point 6 – point g

Regulation (EU) 2017/745

Annex VIII – Section 6.3

Text proposed by the CommissionAmendment
Software which is intended to generate an output that confers a clinical benefit and is used for diagnosis, treatment, prevention, monitoring, prediction, prognosis, compensation or alleviation of a disease or condition is classified as class I, unless the output is intended for a disease or condition:A medical device software which is intended to generate an output that confers a clinical benefit is classified as class I, unless the output is intended for:
- Determining clinical management in a critical situation with a risk of causing death or an irreversible deterioration of a person's state of health, in which case it is classified as class III;
- Determining clinical management in a serious situation with a risk of causing a serious deterioration of a person's state of health or a surgical intervention, or driving clinical management in a critical situation in which cases it is classified as class IIb;
- Determining clinical management in a non-serious situation or driving clinical management in a serious situation or informing clinical management in a critical or serious situation in which cases it is classified as class IIa,
except where the software is a 'simple calculator' intended specifically for use by healthcare professionals to inform clinical management in non-time critical situations regardless of the patient condition, and, where the calculation is based on commonly known state-of-the-art clinical practice and presented explicitly and transparently for the professional at the time of use of the software, in which case the software is classified as class I.
(This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)

Or. en

(See wording of Annex VIII - Section 6.3 Rule 11, Regulation (EU) 2017/745.)

Justification

Commission proposal for a new rule 11 for software classification is ambiguous and does not properly achieve the aim of better proportionality, simplification and allowing self-certification for a larger group of medical device software products.

Amendment 808

Andreas Glück, Stine Bosse, Billy Kelleher

Proposal for a regulation

Annex I – paragraph 1 – point 6 – point g

Regulation (EU) 2017/745

Annex VIII – Section 6.3 – subparagraph 1 – introductory part

Text proposed by the CommissionAmendment
Software which is intended to generate an output that confers a clinical benefit and is used for diagnosis, treatment, prevention, monitoring, prediction, prognosis, compensation or alleviation of a disease or condition is classified as class I, unless the output is intended for a disease or condition:Software which is intended for a medical purpose and generates an output that is used is used for diagnosis, treatment, prevention, monitoring, prediction, prognosis, compensation or alleviation of a disease or condition is classified as class I, unless the output is intended to address a disease or condition in on of the following situations:

Or. en

Justification

The Commission's classification language for software is unclear and open to interpretation. The amendment aligns the wording with international (IMDRF) classification rules and the Commission's own stated intention — ensuring predictable outcomes, including Class I where patient risk is genuinely low.

Amendment 809

Tiemo Wölken

Proposal for a regulation

Annex I – paragraph 1 – point 6 – point g

Regulation (EU) 2017/745

Annex VIII – Section 6.3 – subparagraph 1 – introductory part

Text proposed by the CommissionAmendment
Software which is intended to generate an output that confers a clinical benefit and is used for diagnosis, treatment, prevention, monitoring, prediction, prognosis, compensation or alleviation of a disease or condition is classified as class I, unless the output is intended for a disease or condition:Software which is intended to generate an output that confers a clinical benefit and is used for diagnosis, treatment, prevention, monitoring, prediction, prognosis, compensation or alleviation of a disease or condition is classified as class I, unless the output is intended:

Or. en

Amendment 810

Aurelijus Veryga

Proposal for a regulation

Annex I – paragraph 1 – point 6 – point g

Regulation (EU) 2017/745

Annex VIII – Section 6.3 – subparagraph 1 – introductory part

Text proposed by the CommissionAmendment
Software which is intended to generate an output that confers a clinical benefit and is used for diagnosis, treatment, prevention, monitoring, prediction, prognosis, compensation or alleviation of a disease or condition is classified as class I, unless the output is intended for a disease or condition:Software which is intended for a medical purpose and to generates an output that is used for diagnosis, treatment, prevention, monitoring, prediction, prognosis, compensation or alleviation of a disease or condition is classified as class I, unless the its output is intended :

Or. en

Amendment 811

Ondřej Knotek, Laurent Castillo, Marie-Luce Brasier-Clain, Viktória Ferenc, Valérie Deloge

Proposal for a regulation

Annex I – paragraph 1 – point 6 – point g

Regulation (EU) 2017/745

Annex VIII – Section 6.3 – subparagraph 1 – introductory part

Text proposed by the CommissionAmendment
Software which is intended to generate an output that confers a clinical benefit and is used for diagnosis, treatment, prevention, monitoring, prediction, prognosis, compensation or alleviation of a disease or condition is classified as class I, unless the output is intended for a disease or condition:Software which is intended for medical purpose and generates an output that confers a clinical benefit and is used for diagnosis, treatment, prevention, monitoring, prediction, prognosis, compensation or alleviation of a disease or condition is classified as class I, unless its output is:

Or. en

Amendment 812

Andreas Glück, Stine Bosse, Billy Kelleher

Proposal for a regulation

Annex I – paragraph 1 – point 6 – point g

Regulation (EU) 2017/745

Annex VIII – Section 6.3 – subparagraph 1 – indent 1

Text proposed by the CommissionAmendment
– in a critical situation with a risk of causing death or an irreversible deterioration of a person's state of health, in which case it is classified as class III;– - to treat or diagnose in a critical situation, in which case it is class III;

Or. en

Justification

The Commission's classification language for software is unclear and open to interpretation. The amendment aligns the wording with international (IMDRF) classification rules and the Commission's own stated intention — ensuring predictable outcomes, including Class I where patient risk is genuinely low.

Amendment 813

Tiemo Wölken

Proposal for a regulation

Annex I – paragraph 1 – point 6 – point g

Regulation (EU) 2017/745

Annex VIII – Section 6.3 – subparagraph 1 – indent 1

Text proposed by the CommissionAmendment
– in a critical situation with a risk of causing death or an irreversible deterioration of a person's state of health, in which case it is classified as class III;– to treat or diagnose a disease or condition in a critical situation , in which case it is classified as class III;

Or. en

Amendment 814

Andreas Glück, Stine Bosse, Billy Kelleher

Proposal for a regulation

Annex I – paragraph 1 – point 6 – point g

Regulation (EU) 2017/745

Annex VIII – Section 6.3 – subparagraph 1 – indent 2

Text proposed by the CommissionAmendment
– in a serious situation with a risk of causing a serious deterioration of a person's state of health or a surgical intervention, or to drive clinical management in a critical situation in which cases it is classified as class IIb;– - to treat or diagnose in a serious situation, or to drive clinical management in a critical situation, in which cases it is class IIb;

Or. en

Justification

The Commission's classification language for software is unclear and open to interpretation. The amendment aligns the wording with international (IMDRF) classification rules and the Commission's own stated intention — ensuring predictable outcomes, including Class I where patient risk is genuinely low.

Amendment 815

Tiemo Wölken

Proposal for a regulation

Annex I – paragraph 1 – point 6 – point g

Regulation (EU) 2017/745

Annex VIII – Section 6.3 – subparagraph 1 – indent 2

Text proposed by the CommissionAmendment
– in a serious situation with a risk of causing a serious deterioration of a person's state of health or a surgical intervention, or to drive clinical management in a critical situation in which cases it is classified as class IIb;– to threat or diagnose a disease or condition in a serious situation , or to drive clinical management of a disease or condition in a critical situation in which cases it is classified as class IIb;

Or. en

Amendment 816

Tiemo Wölken

Proposal for a regulation

Annex I – paragraph 1 – point 6 – point g

Regulation (EU) 2017/745

Annex VIII – Section 6.3 – subparagraph 1 – indent 3

Text proposed by the CommissionAmendment
– in a non-serious situation, or to drive clinical management in a serious situation or to inform clinical management in a critical or serious situation in which cases it is classified as class IIa.;– to treat or diagnose a disease or condition in a non-serious situation, or to drive clinical management of a disease or condition in a serious situation or to inform clinical management for a disease or condition in a critical situation in which cases it is classified as class IIa.

Or. en

Amendment 817

Andreas Glück, Stine Bosse, Billy Kelleher

Proposal for a regulation

Annex I – paragraph 1 – point 6 – point g

Regulation (EU) 2017/745

Annex VIII – Section 6.3 – subparagraph 1 – indent 3

Text proposed by the CommissionAmendment
– in a non-serious situation, or to drive clinical management in a serious situation or to inform clinical management in a critical or serious situation in which cases it is classified as class IIa.;– - to treat or diagnose in a non-serious situation, to drive clinical management in a serious situation or to inform clinical management in a critical situation in which cases it is classified as class IIa.

Or. en

Justification

The Commission's classification language for software is unclear and open to interpretation. The amendment aligns the wording with international (IMDRF) classification rules and the Commission's own stated intention — ensuring predictable outcomes, including Class I where patient risk is genuinely low.

Amendment 818

Letizia Moratti, Dolors Montserrat, Elena Nevado del Campo

Proposal for a regulation

Annex I – paragraph 1 – point 6 – point g a (new)

Regulation (EU) 2017/745

Annex VIII – Section 7.1

Present textAmendment
All devices incorporating, as an integral part, a substance which, if used separately, can be considered to be a medicinal product, as defined in point 2 of Article 1 of Directive 2001/83/EC, including a medicinal product derived from human blood or human plasma, as defined in point 10 of Article 1 of that Directive, and that has an action ancillary to that of the devices, are classified as class III."All devices incorporating, as an integral part, a substance which, if used separately, can be considered to be a medicinal product, as defined in point 2 of Article 1 of Directive 2001/83/EC, including a medicinal product derived from human blood or human plasma, as defined in point 10 of Article 1 of that Directive, and that have a clinically relevant ancillary action contributing to the intended medical purpose, are classified as class III"

Or. en

(2017/745)

Amendment 819

Letizia Moratti, Dolors Montserrat, Elena Nevado del Campo

Proposal for a regulation

Annex I – paragraph 1 – point 6 – point i

Regulation (EU) 2017/745

Annex VIII – Section 7.8

Text proposed by the CommissionAmendment
Devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed by or locally dispersed on or in the human body are classified as:;Devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed by or locally dispersed in the human body are classified as:;

Or. en

Amendment 820

Ondřej Dostál

Proposal for a regulation

Annex I – paragraph 1 – point 6 a (new)

Regulation (EU) 2017/745

Annex VIII – Section 5.2

Text proposed by the CommissionAmendment
(6a) Section 5.2 is replaced by the following:
"
All surgically invasive devices intended for transient use are classified as class IIa unless they:
- are intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with those parts of the body, in which case they are classified as class III;
- are surgical instruments regardless of the body part with which they come into contact, in which case they are classified as class I;
- are intended specifically for use in direct contact with the heart of central circulatory system or the central nervous system, in which case they are classified as class III;
- are intended to supply energy in the form of ionising radiation in which case they are classified as class IIb;
- have a biological effect or are wholly or mainly absorbed in which case they are classified as class IIb; or are intended to administer medicinal products by means of a delivery system, if such administration of a medicinal product is done in a manner that is potentially hazardous taking account of the mode of application, in which case they are classified as class IIb.
"

Or. en

Amendment 821

Ondřej Dostál

Proposal for a regulation

Annex I – paragraph 1 – point 6 b (new)

Regulation (EU) 2017/745

Annex VIII – Section 5.3

Text proposed by the CommissionAmendment
(6b) Section 5.3 is replaced by the following:
"
All surgically invasive devices intended for short-term use are classified as class IIa unless they:
- are intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with those parts of the body, in which case they are classified as class III;
- are intended specifically for use in direct contact with the heart of central circulatory system or the central nervous system, in which case they are classified as class III;
- are intended to supply energy in the form of ionising radiation in which case they are classified as class IIb;
- have a biological effect or are wholly or mainly absorbed in which case they are classified as class III;
- are intended to undergo chemical change in the body in which case they are classified as class IIb, except if the devices are placed in the teeth; or
- are intended to administer medicines, in which case they are classified as class IIb;
- are surgical instruments regardless of the body part with which they come into contact, in which case they are classified as class 1;
"

Or. en

Amendment 822

Viktória Ferenc, Ondřej Knotek, Laurent Castillo, Valérie Deloge

Proposal for a regulation

Annex I – paragraph 1 – point 7 – point a a (new)

Regulation (EU) 2017/746

Annex IX – Section 2.4

Text proposed by the CommissionAmendment
(aa) Section 2.4 is replaced by the following:
"2.4. The manufacturer in question shall inform the notified body which approved the quality management system of any plan for substantial changes to the quality management system or substantial changes to the device range included in the certificate, including the addition of a new product category or a new generic device group to the scope of the certificate. The notified body shall assess the proposed changes, determine whether additional audits or documentary reviews are necessary, and verify whether the quality management system continues to meet the requirements referred to in Section 2.2 after those changes. It shall notify the manufacturer of its decision which shall contain the conclusions of the assessment, and where applicable, the conclusions of any additional audits or reviews. The approval of any substantial change to the quality management system or to the device-range covered by the certificate shall take the form of a supplement to the EU quality management system certificate."

Or. en

Justification

Clarifies the scope of information to be provided and that additional audits or reviews are required only where necessary, reducing unnecessary administrative burden.

Amendment 823

Tiemo Wölken

Proposal for a regulation

Annex I – paragraph 1 – point 7 – point c

Regulation (EU) 2017/745

Annex IX – Section 3.3 – subparagraph 1

Text proposed by the CommissionAmendment
Notified bodies shall periodically carry out appropriate audits and assessments to make sure that the manufacturer in question applies the approved quality management system and the post-market surveillance plan. Those audits and assessments shall include audits on the premises of the manufacturer and, if appropriate, of the manufacturer's suppliers and/or subcontractors. On justified grounds, the audit may be conducted remotely instead of on-site. The notified body shall, where necessary, carry out or ask for tests in order to check that the quality management system is working properly. It shall provide the manufacturer with a surveillance audit report and, if a test has been carried out, with a test report.Notified bodies shall periodically carry out appropriate audits and assessments to make sure that the manufacturer in question applies the approved quality management system and the post-market surveillance plan. Those audits and assessments shall include audits on the premises of the manufacturer and, if appropriate, of the manufacturer's suppliers and/or subcontractors. In exceptional and duly justified cases, the audit may be conducted remotely instead of on-site. The reasons justifying the remote audit shall be documented in the audit report. The notified body shall, where necessary, carry out or ask for tests in order to check that the quality management system is working properly. It shall provide the manufacturer with a surveillance audit report and, if a test has been carried out, with a test report.

Or. en

Amendment 824

Tiemo Wölken

Proposal for a regulation

Annex I – paragraph 1 – point 7 – point c

Regulation (EU) 2017/745

Annex IX – Section 3.3 – subparagraph 2

Text proposed by the CommissionAmendment
The notified body shall carry out the surveillance audits and assessments once every 12 months. However, where justified in light of the results of previous surveillance audits and assessments, and in the absence of any concerns resulting from data from post-market surveillance or vigilance, the notified body shall carry out the surveillance audits and assessments only once every 24 months.;The notified body shall carry out the surveillance audits and assessments at least once every 12 months. However, where justified in light of the results of previous surveillance audits and assessments, and in the absence of any concerns arising from post-market surveillance or vigilance data, the notified body may carry out the surveillance audits and assessments once every 24 months. Notwithstanding the second sentence, the notified body shall carry out a surveillance audit or assessment at an earlier stage where there are reasonable grounds to believe that the safety or performance of the device may be adversely affected.

Or. en

Amendment 825

Tiemo Wölken

Proposal for a regulation

Annex I – paragraph 1 – point 7 – point d – point i

Regulation (EU) 2017/745

Annex IX – Section 3.4 – paragraph 1

Text proposed by the CommissionAmendment
The notified body shall perform short-notice or unannounced audits on the site of the manufacturer and, where appropriate, of the manufacturer's suppliers and/or subcontractors when justified based on concerns related to post-market surveillance or vigilance data or at the request of a competent authority. The short-notice or unannounced audit may be combined with the periodic surveillance assessment referred to in Section 3.3. or be performed in addition to that surveillance assessment.;The notified body shall perform random short-notice or unannounced audits on the site of the manufacturer at least once every five years and, where appropriate, of the manufacturer's suppliers and/or subcontractors The short-notice or unannounced audit may be combined with the periodic surveillance assessment referred to in Section 3.3. or be performed in addition to that surveillance assessment. Where justified on the basis of concerns arising from post-market surveillance or vigilance data or at the request of a competent authority, the notified body may carry out additional random short-notice or unannounced audits within that five-year period.

Or. en

Amendment 826

Tiemo Wölken

Proposal for a regulation

Annex I – paragraph 1 – point 7 – point d – point ii

Regulation (EU) 2017/745

Annex IX – Section 3.4 – paragraph 2

Text proposed by the CommissionAmendment
Within the context of such unannounced on-site audits, the notified body may test an adequate sample of the devices produced or an adequate sample from the manufacturing process to verify that the manufactured device is in conformity with the technical documentation, with the exception of the devices referred to in the second subparagraph of Article 52(8).;Within the context of such unannounced on-site audits, the notified body shall, where appropriate, test an adequate sample of the devices produced or an adequate sample from the manufacturing process to verify that the manufactured device is in conformity with the technical documentation, with the exception of the devices referred to in the second subparagraph of Article 52(8).;

Or. en

Amendment 827

Tiemo Wölken

Proposal for a regulation

Annex I – paragraph 1 – point 7 – point e

Regulation (EU) 2017/745

Annex IX – Section 3.5

Text proposed by the CommissionAmendment
In the case of class III devices, with the exception of well-established technology devices, the surveillance assessment shall also include a test of the approved parts and/or materials that are essential for the integrity of the device, including, where appropriate, a check that the quantities of produced or purchased parts and/or materials correspond to the quantities of finished devices.;In the case of class III devices the surveillance assessment shall also include a test of the approved parts and/or materials that are essential for the integrity of the device, including, where appropriate, a check that the quantities of produced or purchased parts and/or materials correspond to the quantities of finished devices.;

Or. en

Amendment 828

Viktória Ferenc, Ondřej Knotek, Laurent Castillo, Valérie Deloge

Proposal for a regulation

Annex I – paragraph 1 – point 7 – point k a (new)

Regulation (EU) 2017/745

Annex IX – Section 4.10a (new)

Text proposed by the CommissionAmendment
(ka) Changes to the approved device shall require approval from the notified body which issued the EU technical documentation assessment certificate where such changes could adversely affect the safety and performance of the device or the conditions prescribed for use of the device. Where the manufacturer plans to introduce or has introduced any of the abovementioned substantial changes it shall inform the notified body which issued the EU technical documentation assessment certificate thereof.
The notified body shall assess the substantial changes and decide whether the changes require a new conformity assessment in accordance with Article 52 or whether they could be addressed by means of a supplement to the EU technical documentation assessment certificate. In the latter case, the notified body shall determine if the changes shall be assessed prior to or after implementation, notify the manufacturer of its decision and, where the changes are approved, provide it with a supplement to the EU technical documentation assessment certificate.

Or. en

Amendment 829

Ruggero Razza, Michele Picaro

Proposal for a regulation

Annex I – paragraph 1 – point 7 – point p a (new)

Regulation (EU) 2017/745

Annex IX – Section 5.4 – point a

Present textAmendment
Annex IX, Section 5.4 (a)‘Annex IX, Section 5.4 (a)
(a) The quality and safety of devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed by, or locally dispersed in, the human body, shall be verified where applicable and only in respect of the requirements not covered by this Regulation, in accordance with the relevant requirements laid down in Annex I to Directive 2001/83/EC for the evaluation of absorption, distribution, metabolism, excretion, local tolerance, toxicity, interaction with other devices, medicinal products or other substances and potential for adverse reactions.(a) The quality and safety of devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed by, or locally dispersed in, the human body, shall also be assessed where applicable for aspects relating to the absorption, distribution, metabolism, excretion, local tolerance, toxicity, interaction with other devices, medicinal products or other substances, and the potential for adverse reactions, taking into account the state of the art and the characteristics of the substance or combination of substances.

Or. it

((EU) 2017/745)

Justification

This amendment modifies a provision that has remained unchanged in the Commission proposal, removing the automatic reference to requirements designed for medicinal products. However, a rigorous assessment of the relevant safety aspects remains ensured, through criteria specifically adapted to medical devices and their characteristics.

Amendment 830

Letizia Moratti, Dolors Montserrat, Elena Nevado del Campo

Proposal for a regulation

Annex I – paragraph 1 – point 7 – point p a (new)

Regulation (EU) 2017/745

Annex IX – Section 5.4 – point a

Present textAmendment
The quality and safety of devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed by, or locally dispersed in, the human body, shall be verified where applicable only in respect of the requirements not covered by this Regulation, in accordance with the relevant requirements laid down in Annex I to Directive 2001/83/EC for the evaluation of absorption, distribution, metabolism, excretion, local tolerance, toxicity, interaction with other devices, medicinal products or other substances and potential for adverse reactions."The quality and safety of devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed by, or locally dispersed in, the human body, shall be verified where applicable for the matter referring to absorption, distribution, metabolism, excretion, local tolerance, toxicity, interaction with other devices, medicinal products or other substances and potential for adverse reactions and having regard to the state of the art and to the characteristics of the substance(s) concerned."

Or. en

(2017/745)

Justification

Justification

Removing the reference to Directive 2001/83/EC (the legislation governing medicinal products) eliminates an unnecessary source of regulatory uncertainty. Medical devices and medicinal products operate through different mechanisms and are subject to separate regulatory frameworks. It is therefore neither appropriate nor scientifically justified to require medical device manufacturers to address the aspects set out in essential requirement 12.2 using an approach developed for medicinal products, as this may unnecessarily hinder innovation and delay access to products that meet emerging healthcare needs.

To maintain a high level of patient safety, the amendment preserves the manufacturer's obligation to rigorously assess those aspects through an approach specifically designed for medical devices, ensuring equivalent safety outcomes. This is consistent with the initiative’s main objectives of simplification, legal certainty, and regulatory coherence for medical devices within the EU.

Amendment 831

Tiemo Wölken

Proposal for a regulation

Annex I – paragraph 1 – point 9 – point c

Regulation (EU) 2017/745

Annex XI – Section 7 – paragraph 2

Text proposed by the CommissionAmendment
In the case of class III devices, other than well-established technology devices, surveillance shall also include a check that the quantities of produced or purchased raw material or crucial components approved for the type correspond to the quantities of finished devices.;In the case of class III devices, surveillance shall also include a check that the quantities of produced or purchased raw material or crucial components approved for the type correspond to the quantities of finished devices.;

Or. en

Amendment 832

Ondřej Dostál

Proposal for a regulation

Annex I – paragraph 1 – point 12 – point a – point ii

Regulation (EU) 2017/745

Annex XIV – Section 1 – point a – paragraph 2

Text proposed by the CommissionAmendment
Points (b) to (e) shall not apply to devices for which confirmation of safety and performance based on clinical data is not deemed appropriate in accordance with Article 61(10).;Points (b) to (e) shall not apply to devices for which confirmation of safety and performance based on clinical data is not deemed appropriate in accordance with Article 61(10).;

Or. en

Justification

"Shall" in Commission proposal is stronger wording than "may" in amendment 127.

Amendment 833

Ignazio Roberto Marino

on behalf of the Verts/ALE Group

Proposal for a regulation

Annex I – paragraph 1 – point 12 – point b

Regulation (EU) 2017/745

Annex XIV – Section 3

Text proposed by the CommissionAmendment
(b) in Section 3, the second and third indents are replaced by the following:deleted
‘- Biological: the device uses the same or similar materials or substances in contact with the same human tissues or body fluids for a similar kind and duration of contact and similar release characteristics of substances, including degradation products and leachables;
– Clinical: the device is used for the same or similar clinical condition or purpose, including similar severity and stage of disease, at the same site in the body, in a similar population, including as regards age, anatomy and physiology; has the same kind of user; has similar relevant critical performance in view of the expected clinical effect for a specific intended purpose.;’

Or. en

Justification

Maintain current language as concerns equivalence. Equivalence should be accepted in the 'same' conditions, not 'same or similar'

Amendment 834

Tiemo Wölken

Proposal for a regulation

Annex I – paragraph 1 – point 12 – point b

Regulation (EU) 2017/745

Annex XIV – Section 3

Text proposed by the CommissionAmendment
(b) in Section 3, the second and third indents are replaced by the following:deleted
‘- Biological: the device uses the same or similar materials or substances in contact with the same human tissues or body fluids for a similar kind and duration of contact and similar release characteristics of substances, including degradation products and leachables;
– Clinical: the device is used for the same or similar clinical condition or purpose, including similar severity and stage of disease, at the same site in the body, in a similar population, including as regards age, anatomy and physiology; has the same kind of user; has similar relevant critical performance in view of the expected clinical effect for a specific intended purpose.;’

Or. en

Amendment 835

Valentina Palmisano

Proposal for a regulation

Annex I – paragraph 1 – point 12 – point b

Regulation (EU) 2017/745

Annex XIV – Section 3

Text proposed by the CommissionAmendment
(b) in Section 3, the second and third indents are replaced by the following:deleted
‘- Biological: the device uses the same or similar materials or substances in contact with the same human tissues or body fluids for a similar kind and duration of contact and similar release characteristics of substances, including degradation products and leachables;
– Clinical: the device is used for the same or similar clinical condition or purpose, including similar severity and stage of disease, at the same site in the body, in a similar population, including as regards age, anatomy and physiology; has the same kind of user; has similar relevant critical performance in view of the expected clinical effect for a specific intended purpose.;’

Or. en

Amendment 836

Tiemo Wölken

Proposal for a regulation

Annex I a (new)

Regulation (EU) 2017/745

Annex XVIIa (new)

Text proposed by the CommissionAmendment
ANNEX XVIII
Minimum information to be provided in the notification of an anticipated interruption or discontinuation of the supply of certain devices.
For the purposes of Article 10a, the notification shall contain at least the following information:
1. Administrative information
- Name of the national competent authority (NCA) to which the notification is submitted.
- Type of notification: initial notification; additional information (voluntary); follow-up information (voluntary).
- Date of notification. Reference number assigned by the manufacturer (if any).
- Reference number assigned by the national competent authority (where applicable).
2. Information on the submitter of the notification
- Status of submitter: manufacturer; authorised representative (where mandated to act on behalf of the manufacturer); other entity (acting on behalf of the manufacturer).
3. Manufacturer information
- Manufacturer organisation name.
- Single Registration Number (SRN). Where the SRN is provided and the manufacturer is registered in EUDAMED, completion of the remaining fields in this Section shall not be required.
- Contact details (address, telephone number and email address).
4. Authorised representative information (where applicable)
- Authorised representative organisation name.
- Single Registration Number (SRN). Where the SRN is provided and the authorised representative is registered in EUDAMED, completion of the remaining fields in this Section shall not be required.
- Contact details.
5. Other entity (where applicable)
- Organisation completing the notification on behalf of the manufacturer.
- Contact details (address, telephone number and email address).
6. Device information
- Risk class.
- Device identification:
- UDI-DI/EUDAMED-DI (where applicable); Basic UDI-DI/EUDAMED-DI (where applicable).
- Where the device is not registered in EUDAMED or does not have a UDI-DI or EUDAMED-DI, provide: model; catalogue/reference number; nomenclature system; nomenclature code; nomenclature text; commercial/brand/common name; intended purpose according to the instructions for use (or attach the IFU, voluntarily).
7. Description of the anticipated interruption or discontinuation of supply
- Interruption or discontinuation.
- Expected start date and expected end date by Member State.
- Member States where the device is marketed.
- Member States affected. Information on notifications sent pursuant to Article 10a(1), including dates of notification to health institutions and healthcare professionals, authorised representatives (where applicable), importers (where applicable) and distributors.
- Reason for the anticipated interruption or discontinuation of supply, including one or more of the following categories: manufacturing issues; quality or safety issues; distribution or supply-chain issues; unexpected increase in demand; commercial reasons; regulatory or conformity-assessment issues; exceptional circumstances or force majeure; any other reason (to be specified).
- Assessment of the impact of the anticipated interruption or discontinuation of supply (where available), including whether the device is life-sustaining or life-saving, intended for a specific patient population, has equivalent alternatives available, affects access to treatment, or has a significant market share in one or more Member States.
8. Additional information relating to the anticipated interruption or discontinuation of supply (voluntary)
- Possible mitigation measures.
- Possibility for redistribution of Union or global stock. Availability of an equivalent or alternative device intended for the same intended purpose.
- Information on remaining inventory or available stock within the Union, where known.
8.1. Detailed categories for reasons (Section 7)
8.1.1 Manufacturing issues
- Unavailability of components, materials or raw materials.
- Unavailability of substances of human or animal origin, where applicable.
- Failure or unavailability of manufacturing equipment or production lines.
- Delays in manufacturing, testing, final inspection or release of finished devices.
- Non-compliance of the manufacturer’s quality management system. Transfer, closure or temporary suspension of a manufacturing site.
- Manufacturing capacity constraints.
- Failure, insolvency or disruption affecting a critical supplier or subcontractor.
- Other manufacturing issues.
8.1.2. Quality or safety issues
Non-conformity or quality defects affecting the device.
Failure of the device to achieve its intended performance.
Serious incidents or an increased trend in incidents.
Field safety corrective actions.
Withdrawals, recalls or restrictions on the making available of the device.
Suspension, restriction or termination of production or supply as a preventive or corrective measure. Cybersecurity vulnerabilities affecting, or potentially affecting, the safety or performance of the device. Other quality or safety issues.
8.1.3. Distribution or supply-chain issues
- Export restrictions or prohibitions.
- Import or export delays.
- Customs clearance delays.
- Transport, storage or logistics disruptions.
- Disruption affecting an importer, distributor, authorised representative or logistics provider.
- Shortage or unavailability of packaging, labelling or other materials necessary for the supply of the device.
- Other distribution or supply-chain issues.
8.1.4. Unexpected increase in demand
- Public-health emergencies. Seasonal, epidemiological or other significant changes in clinical demand.
- Changes in clinical practice or patterns of use.
- Unavailability or reduced availability of equivalent, alternative or competing devices.
- Unexpected increase in orders or consumption.
- Other circumstances resulting in increased demand.
8.1.5. Commercial reasons
- Change in the manufacturer’s commercial or business strategy.
- Discontinuation of a device, device model, product line or commercial activity.
- Lack of commercial viability.
- Insolvency, restructuring, merger, acquisition or cessation of activities affecting the manufacturer or a critical supplier.
- Termination of contractual arrangements with a supplier, subcontractor, importer or distributor.
- Other commercial reasons.
8.1.6. Regulatory or conformity-assessment issues
- Delay in the conformity-assessment procedure.
- Delay in the issuance, renewal or amendment of a certificate.
- Expiry, suspension, restriction or withdrawal of a certificate.
- Termination or suspension of the contractual relationship with a notified body. Lack of notified-body capacity.
- Changes necessary to maintain compliance with this Regulation.
- Delay in implementing corrective or preventive measures required by a competent authority or notified body.
- Other regulatory or conformity-assessment issues.
8.1.7. Exceptional circumstances or force majeure
- Natural disasters.
- Fire, flood or other major damage to manufacturing or storage facilities.
- Armed conflict, civil unrest or sanctions.
- Pandemics or other public-health emergencies.
- Disruption to energy supplies, communications systems or other critical infrastructure.
- Other exceptional circumstances beyond the manufacturer’s reasonable control.
8.1.8. Any other reason
- Any other reason, which shall be specified.

Or. en

Amendment 837

Adam Jarubas

Proposal for a regulation

Annex II – paragraph 1 – point 1 – point a a (new)

Regulation (EU) 2017/746

Annex I – Sections 16.4a (new) and 16.4b (new)

Text proposed by the CommissionAmendment
(aa) the following Sections 16.5 and 16.6 are added:
‘
16.5 Connected devices shall comply with the essential cybersecurity requirements set out in Annex I, Part I, point 2, letter (a) to (l) of Regulation (EU) 2024/2847 of the European Parliament and of the Council, taking into consideration benefit-risk ratio of the device and intended user.
16.6 Manufacturer of connected devices shall fulfil requirements specified in Annex I, Part II of regulation mentioned in paragraph 17.5.1.\
’

Or. en

Amendment 838

Tiemo Wölken

Proposal for a regulation

Annex II – paragraph 1 – point 1 – point b – point i

Regulation (EU) 2017/746

Annex I – Section 20.1 – second sentence of the of the first paragraph

Text proposed by the CommissionAmendment
Such information may appear on the device itself, on the packaging or in the instructions for use, taking into account the following:;Such information may appear on the device itself, on the packaging or in the instructions for use and shall, if the manufacturer has a website, be made available and kept up to date on the website taking into account the following:;

Or. en

Amendment 839

Aurelijus Veryga

Proposal for a regulation

Annex II – paragraph 1 – point 1 – point b – point iv

Regulation (EU) 2017/746

Annex I – Section 20.1 – point f

Text proposed by the CommissionAmendment
(f) When the device is intended for professional use only, instructions for use may be provided to the user in non-paper format (e.g. electronic).;(f) Instructions for use may be provided to the user in non-paper format such as electronic format. Users shall have the possibility to obtain instructions for use in paper format upon request.;

Or. en

Amendment 840

Viktória Ferenc, Ondřej Knotek

Proposal for a regulation

Annex II – paragraph 1 – point 1 – point b – point iv

Regulation (EU) 2017/746

Annex I – Section 20.1 – point f

Text proposed by the CommissionAmendment
(f) When the device is intended for professional use only, instructions for use may be provided to the user in non-paper format (e.g. electronic).;(f) Instructions for use may be provided to the user in non-paper format such as electronic format. Users shall have the possibility to obtain instructions for use in paper format upon request.

Or. en

Justification

The proposed amendment promotes the use of electronic instructions for use and other non-paper formats, which can improve access to the most current information, support digitalisation and reduce unnecessary administrative burden. At the same time, it ensures that users retain the ability to request and receive instructions in paper format where needed, thereby safeguarding accessibility, inclusiveness and user choice. The amendment therefore combines flexibility and innovation with appropriate user protections.

Amendment 841

Tiemo Wölken

Proposal for a regulation

Annex II – paragraph 1 – point 1 – point b – point v

Regulation (EU) 2017/746

Annex I – Section 20.1 – point k

Text proposed by the CommissionAmendment
(k) For devices that are used exclusively with a medicinal product in accordance with Article 19 of [Proposal for a Directive on the Union code relating to medicinal products for human use, and repealing Directive 2011/83/EC and Directive 2009/35/EC] and packaged together with a medicinal product, the instructions for use may be included, where needed, as part of the co-packaging of the medicinal product with the device. Moreover, the information on the label of the device may be limited to the particulars referred to in Section 20.2., points (a) and (c), where, following agreement of the competent authority responsible for the authorisation of the medicinal product, the following conditions are met:(k) For devices that are used exclusively with a medicinal product in accordance with Article 19 of [Proposal for a Directive on the Union code relating to medicinal products for human use, and repealing Directive 2011/83/EC and Directive 2009/35/EC] and packaged together with a medicinal product, the instructions for use shall be included, where needed, as part of the co-packaging of the medicinal product with the device. Moreover, the information on the label of the device may be limited to the particulars referred to in Section 20.2., points (a) and (c), where, following agreement of the competent authority responsible for the authorisation of the medicinal product, the following conditions are met:

Or. en

Amendment 842

Tiemo Wölken

Proposal for a regulation

Annex II – paragraph 1 – point 1 – point b – point v

Regulation (EU) 2017/746

Annex I – Section 20.1 – point k – point ii a (new)

Text proposed by the CommissionAmendment
(iia) electronic or digital means used to provide access to the instructions for use shall comply with Regulation (EU) 2016/679 and shall not permit the identification, profiling or tracking of patients beyond what is necessary for the provision of that information.

Or. en

Amendment 843

Tiemo Wölken

Proposal for a regulation

Annex II – paragraph 1 – point 4 – point a

Regulation (EU) 2017/746

Annex VI – Part B – point 29a (new)

Text proposed by the CommissionAmendment
(30) identification number of the notified body responsible for the conformity assessment procedures set out in Article 48.

Or. en

Amendment 844

Tiemo Wölken

Proposal for a regulation

Annex II – paragraph 1 – point 5 – point d

Regulation (EU) 2017/746

Annex VII – Section 1.2.9

Text proposed by the CommissionAmendment
The notified body shall have documented procedures in place to offer and carry out dialogues with the manufacturer before and after an application for conformity assessment is lodged.;The requirements laid down in this Section shall in no way preclude exchanges of technical information, regulatory guidance and scientific advice between a notified body and a manufacturer applying for conformity assessment. The notified body shall have documented procedures in place to offer and carry out dialogues, including pre- and post application, with the manufacturer before and after an application for conformity assessment is lodged. In the context of the structured dialogue, requests from the manufacturer shall respect the independence, objectivity and impartiality of the notified body. They shall be limited to specific scientific, technical or regulatory matters and shall not seek advice on how to demonstrate or achieve compliance with the requirements of this Regulation. Responsibility for ensuring compliance with those requirements shall remain with the manufacturer;

Or. en

Amendment 845

András Tivadar Kulja

Proposal for a regulation

Annex II – paragraph 1 – point 5 – point d

Regulation (EU) 2017/746

Annex VII – Section 1.2.9

Text proposed by the CommissionAmendment
The notified body shall have documented procedures in place to offer and carry out dialogues with the manufacturer before and after an application for conformity assessment is lodged.;The notified body shall have documented procedures in place to offer and carry out dialogues with the manufacturer before and after an application for conformity assessment is lodged. These dialogues may include structured and interactive exchanges, including pre-submission consultations, and consultations, throughout the conformity assessment procedure.;

Or. en

Amendment 846

Tiemo Wölken

Proposal for a regulation

Annex II – paragraph 1 – point 5 – point p

Regulation (EU) 2017/746

Annex VII – Section 4.2 – point a

Text proposed by the CommissionAmendment
That description shall include which languages are acceptable for submission of documentation and for any related correspondence and the modalities for carrying out the dialogue referred to in Section 1.2.9 of this Annex before an application is lodged.;publish a publicly available description of the application procedure by which manufacturers can obtain certification from it. That description shall include the languages acceptable for the submission of documentation and any related correspondence, and the modalities for carrying out the dialogue referred to in Section 1.2.9 of this Annex prior to the submission of an application.

Or. en

Amendment 847

Andreas Glück, Stine Bosse, Billy Kelleher

Proposal for a regulation

Annex II – paragraph 1 – point 5 – point r – point iii

Regulation (EU) 2017/745

Annex VII – Section 4.5.1

Text proposed by the CommissionAmendment
– to leverage evidence from previously performed assessments.;– to leverage and, where appropriate, rely on assessments, audit results and evidence previously performed by another notified body designated under this Regulation and other certification organisation; – to avoid unnecessary duplication of conformity assessment activities already performed under this Regulation; – to document and justify any repetition of audits, inspections or technical documentation assessments on the basis of identified risks or significant changes.

Or. en

Justification

Manufacturers are frequently required to repeat assessments already performed by another notified body or recognised certification organisation, creating unnecessary administrative burden and cost without improving patient safety. Requiring notified bodies to rely on existing assessments, avoid duplication and justify any repetition focuses regulatory resources on genuine risks and supports a more efficient, consistent conformity assessment system across the Union.

Amendment 848

Ignazio Roberto Marino

on behalf of the Verts/ALE Group

Proposal for a regulation

Annex II – paragraph 1 – point 6 – point a

Regulation (EU) 2017/746

Annex IX – Section 2.3 – paragraph 3 – intent 1

Text proposed by the CommissionAmendment
– for class B devices, one device;– for class B devices, at least one representative device per category of devices ;

Or. en

Amendment 849

Ignazio Roberto Marino

on behalf of the Verts/ALE Group

Proposal for a regulation

Annex II – paragraph 1 – point 6 – point a

Regulation (EU) 2017/746

Annex IX – Section 2.3 – paragraph 3 – intent 2

Text proposed by the CommissionAmendment
– for class C devices, one device per generic device group.– for class C devices, at least one representative device per generic device group.

Or. en

Amendment 850

Tiemo Wölken

Proposal for a regulation

Annex II – paragraph 1 – point 6 – point c

Regulation (EU) 2017/746

Annex IX – Section 3.3 – paragraph 1

Text proposed by the CommissionAmendment
Notified bodies shall periodically carry out appropriate audits and assessments to make sure that the manufacturer in question applies the approved quality management system and the post-market surveillance plan. Those audits and assessments shall include audits on the premises of the manufacturer and, if appropriate, of the manufacturer's suppliers and/or subcontractors. On justified grounds, the audit may be conducted remotely instead of on-site. The notified body shall, where necessary, carry out or ask for tests in order to check that the quality management system is working properly. It shall provide the manufacturer with a surveillance audit report and, if a test has been carried out, with a test report.Notified bodies shall periodically carry out appropriate audits and assessments to make sure that the manufacturer in question applies the approved quality management system and the post-market surveillance plan. Those audits and assessments shall include audits on the premises of the manufacturer and, if appropriate, of the manufacturer's suppliers and/or subcontractors. In exceptional and duly justified cases, the audit may be conducted remotely instead of on-site. The reasons justifying the remote audit shall be documented in the audit report. The notified body shall, where necessary, carry out or ask for tests in order to check that the quality management system is working properly. It shall provide the manufacturer with a surveillance audit report and, if a test has been carried out, with a test report.

Or. en

Amendment 851

Tiemo Wölken

Proposal for a regulation

Annex II – paragraph 1 – point 6 – point c

Regulation (EU) 2017/746

Annex IX – Section 3.3 – paragraph 2

Text proposed by the CommissionAmendment
The notified body shall carry out the surveillance audits and assessments once every 12 months. However, where justified in light of the results of previous surveillance audits and assessments, and in the absence of any concerns resulting from data from post-market surveillance or vigilance, the notified body shall carry out the surveillance audits and assessments only once every 24 months.;The notified body shall carry out the surveillance audits and assessments at least once every 12 months. However, where justified in light of the results of previous surveillance audits and assessments, and in the absence of any concerns arising from post-market surveillance or vigilance data, the notified body may carry out the surveillance audits and assessments once every 24 months. Notwithstanding the second sentence, the notified body shall carry out a surveillance audit or assessment at an earlier stage where there are reasonable grounds to believe that the safety or performance of the device may be adversely affected.

Or. en

Amendment 852

Laurent Castillo, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain, Valérie Deloge

Proposal for a regulation

Annex II – paragraph 1 – point 6 – point c

Regulation (EU) 2017/745

Annex IX – Section 3.3 – paragraph 2

Text proposed by the CommissionAmendment
The notified body shall carry out the surveillance audits and assessments once every 12 months. However, where justified in light of the results of previous surveillance audits and assessments, and in the absence of any concerns resulting from data from post-market surveillance or vigilance, the notified body shall carry out the surveillance audits and assessments only once every 24 months.’;The notified body shall carry out the surveillance audits and assessments once every 12 months. However, where justified in light of the results of previous surveillance audits and assessments, and in the absence of any concerns resulting from data from post-market surveillance or vigilance, the notified body shall carry out the surveillance audits and assessments only once every 36 months.’;

Or. fr

Amendment 853

Tiemo Wölken

Proposal for a regulation

Annex II – paragraph 1 – point 6 – point d – point i

Regulation (EU) 2017/746

Annex IX – Section 3.4 – paragraph 1

Text proposed by the CommissionAmendment
3.4. The notified body shall perform audits, at short notice or unannounced, on the site of the manufacturer and, where appropriate, the site of the manufacturer’s suppliers and/or subcontractors, when justified based on concerns related to post-market surveillance or vigilance data or at the request of a competent authority. The short-notice or unannounced audit may be combined with the periodic surveillance assessment referred to in Section 3.3. or be performed in addition to that surveillance assessment.;3.4. The notified body shall perform random audits, at short notice or unannounced, on the site of the manufacturer at least once every five years and, where appropriate, the site of the manufacturer’s suppliers and/or subcontractors, . The short-notice or unannounced audit may be combined with the periodic surveillance assessment referred to in Section 3.3. or be performed in addition to that surveillance assessment. Where justified on the basis of concerns arising from post-market surveillance or vigilance data or at the request of a competent authority, the notified body may carry out additional random audits, at short notice or unannounced, within that five-year period.

Or. en

Amendment 854

Laurent Castillo, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain, Valérie Deloge

Proposal for a regulation

Annex II – paragraph 1 – point 6 – point f

Regulation (EU) 2017/745

Annex IX – Section 3.7.

Text proposed by the CommissionAmendment
3.7. If the notified body finds a divergence between the sample taken from the devices produced or from the market and the specifications laid down in the technical documentation or the approved design, it shall suspend or withdraw the relevant certificate or impose conditions or limitations on it.’;3.7. If the notified body finds a divergence between the sample taken from the devices produced or from the market and the specifications laid down in the technical documentation or the approved design, it shall suspend or withdraw the relevant certificate or impose conditions or limitations on it, according to the risk the divergence presents to the patient.’;

Or. fr

Amendment 855

Laurent Castillo, Marie-Luce Brasier-Clain, Valérie Deloge

Proposal for a regulation

Annex II – paragraph 1 – point 6 – point l a (new)

Regulation (EU) 2017/746

Annex IX – Section 4.10

Text proposed by the CommissionAmendment
(la) Section 4.10 is amended as follows:
Changes to the approved device shall require approval from the notified body which issued the EU technical documentation assessment certificate where such changes could significantly affect the safety and performance of the device or the conditions prescribed for use of the device. Where the manufacturer plans to introduce or has made any of the above-mentioned changes, it shall inform the notified body which issued the EU technical documentation assessment certificate thereof. The notified body shall assess the planned significant changes and decide whether they require a new conformity assessment in accordance with Article 52 or whether they could be addressed by means of a supplement to the EU technical documentation assessment certificate. In the latter case, the notified body shall assess the changes, notify the manufacturer of its decision and, where the changes are approved, provide it with a supplement to the EU technical documentation assessment certificate.

Or. fr

Amendment 856

Kateřina Konečná

Proposal for a regulation

Annex II – paragraph 1 – point 11 – point a – point iii a (new)

Regulation (EU) 2017/745

Annex XIV – Section 3

Text proposed by the CommissionAmendment
(iiia) Part A - Section 3, Criteria for claims of equivalence is amended as follows:
Biological: the device uses the same materials or substances in contact with the same human tissues or body fluids for a similar kind and duration of contact and similar release characteristics of substances, including degradation products and leachables;
Clinical: the device is used for the same clinical condition or purpose, including similar severity and stage of disease, at the same site in the body, in a similar population, including as regards age, anatomy and physiology; has the same kind of user; has similar relevant critical performance in view of the expected clinical effect for a specific intended purpose.’

Or. en

Amendment 857

Tiemo Wölken

Proposal for a regulation

Annex II a (new)

Regulation (EU) 2017/746

ANNEX XVI new

Text proposed by the CommissionAmendment
ANNEX XVI - Minimum information to be provided in the notification of an anticipated interruption or discontinuation of the supply of certain in vitro diagnostic medical devices
For the purposes of Article 10a, the notification shall contain at least the following information:
1. Administrative information
- Name of the national competent authority (NCA) to which the notification is submitted.
- Type of notification: initial notification; additional information (voluntary); follow-up information (voluntary).
- Date of notification.
- Reference number assigned by the manufacturer (if any).
- Reference number assigned by the national competent authority (where applicable).
2. Information on the submitter of the notification
- Status of submitter: manufacturer; authorised representative (where mandated to act on behalf of the manufacturer); other entity (acting on behalf of the manufacturer).
3. Manufacturer information Manufacturer organisation name.
- Single Registration Number (SRN).
- Where the SRN is provided and the manufacturer is registered in EUDAMED, completion of the remaining fields in this Section shall not be required.
- Contact details (address, telephone number and email address).
4. Authorised representative information (where applicable)
- Authorised representative organisation name.
- Single Registration Number (SRN). Where the SRN is provided and the authorised representative is registered in EUDAMED, completion of the remaining fields in this Section shall not be required.
- Contact details.
5. Other entity (where applicable)
- Organisation completing the notification on behalf of the manufacturer.
- Contact details (address, telephone number and email address).
6. Device information
Risk class.
- Device identification: UDI-DI/EUDAMED-DI (where applicable); Basic UDI-DI/EUDAMED-DI (where applicable).
- Where the device is not registered in EUDAMED or does not have a UDI-DI or EUDAMED-DI, provide: model; catalogue/reference number; nomenclature system; nomenclature code; nomenclature text; commercial name/brand name/common name; intended purpose according to the instructions for use (or attach the instructions for use, voluntarily).
7. Description of the anticipated interruption or discontinuation of supply
- Interruption or discontinuation.
- Expected start date and expected end date by Member State.
- Member States where the in vitro diagnostic medical device is marketed.
- Member States affected.
- Information on notifications sent pursuant to Article 10a(1), including dates of notification to health institutions, laboratories, healthcare professionals, authorised representatives (where applicable), importers (where applicable) and distributors.
- Reason for the anticipated interruption or discontinuation of supply, including one or more of the categories set out below.
- Assessment of the impact of the anticipated interruption or discontinuation of supply (where available), including whether the device is essential for diagnosis, screening, monitoring, prognosis, prediction or companion diagnostics; intended for a specific patient population; has equivalent or alternative devices available; affects access to diagnosis or patient management; or has a significant market share in one or more Member States.
Detailed categories for reasons
7.1. Manufacturing issues
- Unavailability of components, materials or raw materials.
- Unavailability of substances of human or animal origin, where applicable.
- Failure or unavailability of manufacturing equipment or production lines.
- Delays in manufacturing, testing, final inspection or release of finished devices.
- Non-compliance of the manufacturer's quality management system.
- Transfer, closure or temporary suspension of a manufacturing site.
- Manufacturing capacity constraints.
- Failure, insolvency or disruption affecting a critical supplier or subcontractor.
- Other manufacturing issues.
7.2. Quality or safety issues
- Non-conformity or quality defects affecting the device.
- Failure of the device to achieve its intended performance.
- Serious incidents or an increased trend in incidents.
- Field safety corrective actions.
- Withdrawals, recalls or restrictions on the making available of the device.
- Suspension, restriction or termination of production or supply as a preventive or corrective measure.
- Cybersecurity vulnerabilities affecting, or potentially affecting, the safety, security or performance of the device.
- Other quality or safety issues.
7.3. Distribution or supply-chain issues
- Export restrictions or prohibitions.
- Import or export delays.
- Customs clearance delays.
- Transport, storage or logistics disruptions.
- Disruption affecting an importer, distributor, authorised representative or logistics provider.
- Shortage or unavailability of packaging, labelling or other materials necessary for the supply of the device.
- Other distribution or supply-chain issues.
7.4. Unexpected increase in demand
- Public-health emergencies.
- Disease outbreaks or epidemiological events.
- Changes in clinical or laboratory testing practices.
- Unavailability or reduced availability of equivalent, alternative or competing devices.
- Unexpected increase in testing demand or orders.
- Other circumstances resulting in increased demand.
7.5. Commercial reasons
- Change in the manufacturer's commercial or business strategy.
- Discontinuation of a device, device family, product line or commercial activity.
- Lack of commercial viability. Insolvency, restructuring, merger, acquisition or cessation of activities affecting the manufacturer or a critical supplier.
- Termination of contractual arrangements with a supplier, subcontractor, importer or distributor.
- Other commercial reasons.
7.6. Regulatory or conformity-assessment issues
- Delay in the conformity-assessment procedure.
- Delay in the issuance, renewal or amendment of a certificate.
- Expiry, suspension, restriction or withdrawal of a certificate.
- Termination or suspension of the contractual relationship with a notified body.
- Lack of notified-body capacity.
- Changes necessary to maintain compliance with this Regulation.
- Delay in implementing corrective or preventive measures required by a competent authority or notified body.
- Other regulatory or conformity-assessment issues.
7.7. Exceptional circumstances or force majeure
- Natural disasters.
- Fire, flood or other major damage to manufacturing or storage facilities.
- Armed conflict, civil unrest or sanctions.
- Pandemics or other public-health emergencies.
- Disruption to energy supplies, communications systems or other critical infrastructure.
- Other exceptional circumstances beyond the manufacturer's reasonable control.
7.8. Any other reason
- Any other reason, which shall be specified.
8. Additional information relating to the anticipated interruption or discontinuation of supply (voluntary)
- Possible mitigation measures.
- Possibility for redistribution of Union or global stock.
- Availability of an equivalent or alternative in vitro diagnostic medical device intended for the same intended purpose.
- Information on remaining inventory or available stock within the Union, where known.

Or. en